Regulatory Affairs Specialist Jobs

Job Title: Regulatory Affairs Specialist Company: Bonfils Blood Center Location: Denver, CO Description: Bonfils Blood Center, located in Denver, CO, has become an important part of the healthcare system throughout Colorado. It now operates nine community donor centers, serves over 115 statewide healthcare facilities, collects more than 200,000 units of blood every year, and offers a variety of services to better meet the needs of the community, including the Colorado Marrow Donor Program and Laboratories At Bonfils. Job Description: "I do not work for a company. I work for a community." Job Summary: Under administrative direction, prepares and submits submissions and notifications to the FDA and other regulatory bodies and accrediting agencies as needed. Serves as a regulatory resource to the organization by providing input and opinions that are in compliance with applicable rules and regulations. Conducts regulatory research. Job Responsibilities: 1. Serve as a regulatory resource for organization. 1.1. Remain current in new rules and regulations that affect Bonfils operations and, under direction, assist in revising/improving/developing programs, policies and procedures; and assist in developing long-range plans to accomplish regulatory compliance, training, and development of the mission. 1.2. Assist management in the performance of training and development responsibilities when requested. 2. Serve as regulatory consultant to both external and internal customers. 2.1. Serve as regulatory consultant for Change Requests. 2.2. Apprise management on current regulatory and accrediting issues including licensure, registration, GMP, and other quality assurance issues. 2.3. Help develop and maintain a library/archive of regulatory resource materials, i.e., regulatory memos/correspondence, Standards, Technical Manuals, CFRs, Newsletters, professional correspondence/memos, etc. 2.4. Participate in quality assurance and process improvements teams and other teams as requested. 2.5. Consult as directed with staff and management on matters of quality improvement, quality assurance, quality control, process design/redesign and validation to assure compliance with regulatory agencies and existing policies and procedures. 2.6. Consult with departments on the development and format of policies and procedures 2.7. Maintain a relationship with appropriate professional organizations by attending conferences and workshops. 3. Assist with submissions to regulatory and accrediting agencies 3.1. Assist in the submission of registration for new locations, annual re-registration per site, and assure product listing on each is complete. Submit notices of all changes in products and/or location. Prepare related correspondence, as requested. 3.2. Assist in the submission of license changes and amendments for products as needed. Prepare and keep master files of related correspondence. 3.3. Assist in the submission of Biological Product Deviation Reports to FDA 4. Assist as an audit liaison to outside regulatory and certifying agencies. 4.1. Assist with external inspections and audits. Perform escort duties and maintain records of audit proceedings. 4.2. Complete questionnaires and other correspondence as assigned. 4.3. Perform audits as directed. 5. Monitor for Quality. 5.1. Facilitate and monitor the Product Investigation process. 5.2. Facilitate and monitor the Product Recall process. 5.3. Facilitate and monitor the Lookback and Post Transfusion Disease Transmission processes 5.4. Serve as primary consultant for product suitability issues. 5.5. Conduct audits to assess regulatory and Operating Procedure compliance with GMP, ISO, CMS, AABB, CAP, OSHA, and Bonfils Quality System. Summarize observations, identify significant findings, and submit to management for review and action proposals. Monitor proposed actions to completion. 5.6. Assist in the coordination and monitoring of the Corrective/Preventive Action reporting system. 5.7. Assist in the development and monitoring of quality monitors. 6. Under direction, provide training and continuing education. 6.1. Assist in establishing and directing training programs and continuing education programs (both internal and external) in the areas of compliance and regulatory affairs. 6.2. Participate in educational programs related to blood center activities which have special emphasis in compliance with regulations and standards and quality assurance. Education: Bachelor�s Degree from an accredited college or university in one of the life sciences required. Experience: Experience working in an FDA-regulated industry such as devices, pharmaceuticals, or biologics. Experience in a CAP and/or AABB certified laboratory and/or in a GMP environment. Experience in program and training development and presentation preferred. We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Your Opportunity: Bonfils Blood Center offers a competitive benefits package. Employer Sponsored Benefits: Medical, Dental, 401(k), Employee Assistance Program, Employer Paid Life, Long Term Disability, Accidental Death & Dismemberment, 6 Paid Holidays, Personal Time Off, Tax-Free Reimbursment Accounts, Direct Deposit, Credit Union, Shift Differentials. Voluntary/Optional Benefits: Optional Life, Accidental Death & Dismemberment, Pre-Paid Legal, Home/Auto, Section 529 College Savings Plan. We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Job Title: Program Specialist (regulatory affairs/ clinical research) needed at the NIH! Company: Location: Bethesda, MD Description: Kelly Scientific Resources has an excellent opportunity to work onsite at the National Institutes of Health. The program specilaist will: ' File all incoming submissions and correspondence in appropriate Regulatory binders. ' Ensure that procedures are correctly followed by Office of Regulatory Affairs (ORA) and Contract Re-search Organization (CRO's). ' Create binders for new projects as necessary. ' Track binders, their contents, and work closely with CRO's to develop tracking sheets. ' Serve as a point of contact between DAIT ORA and CRO's. ' Track all documents forwarded to and received from CRO's, including submissions to Health Authori-ties, communications, meeting requests, records of contacts, reports of submissions, and annual reports. ' Reconcile missing and incorrect items by frequent interactions with CRO's. ' Prepare packages of documents to send via e-mail or by mail to all CRO's. ' Work with DAIT Regulatory Affairs Staff to generate agendas for meetings with ORA/CRO's and schedule meetings as necessary (agendas, action items, obtain rooms, and call in numbers). ' Assist Regulatory Staff as liaison with DEAS by reviewing accuracy of travel arrangements, travel or-ders, as well as keeping a spreadsheet of updated travel expenses. ' Create and maintain other Regulatory Affairs and Quality Assurance files such as personnel, travel, cor-respondence, agendas, clinical trial agreements, program meetings, etc. ' Assist in the development and approval of project work instructions and standard operating procedures related to their work function for use by the Division. ' Work with ORO staff to develop and implement databases as tracking tools that will generate reports. Requirements: ' Bachelor's degree with at least 2 years experience in a related field preferred. ' Detailed oriented, well organized, and capacity to analyze data. ' Strong skills in Microsoft Office Suite.

Job Title: Regulatory Affairs Specialist II Company: Location: Atlanta, GA Description: WANTED FOR IMMEDIATE HIRE REGULATORY AFFAIRS SPECIALIST II Do you have domestic and international submissions experience? Can you provide regulatory support for product teams? Can you and have you prepared 501k's, IDE's, PMA or other international submissions? Can you provide technical interface with the FDA, international reviewers and answer questions? IF YOU CAN ANSWER YES TO THESE-READ ON!!!! We are searching for a talented Regulatory Affairs Specialist II to: · Provide information for international product registrations · Provide product labeling for regulatory compliance · Provide support for CE marking including: prep and maintenance for tech files and dossiers. IF YOU CAN DO THESE THINGS-KEEP READING- YOU'RE GETTING CLOSE! QUALIFICATIONS: Be able to prioritize/terrific communications skills (both written and verbal)/self motivated/computer literate/goal oriented/knowledge of med device registration/licensing in: JAPAN, CANADA, AUSTRALIA, LATIN AMERICA AND ASIC-PACIFIC EDUCATION: BS or BA TECHNICAL: BIOLOGY, CHEMISTRY, PHYSIOLOGY, ENGINEERING, MEDICAL OR LAW If all of this is you (and more) contact us immediately! COMPENSATION: COMPETITIVE + BONUS **** Only qualified candidates will be considered and contacted **** Click here to apply online

Job Title: Senior Regulatory Affairs Specialist Company: STAAR Surgical Co Location: Monrovia, CA Description: Company Overview STAAR Surgical Company is at the vanguard of minimally invasive ophthalmic vision enhancement and technology. We believe in the importance of improving the efficiency, convenience, and comfort of corrective eye surgery for both medical professionals and patients. It is for this reason that we continually evaluate our existing products to ensure that we are providing the latest cataract, refractive error, and glaucoma treatments. From our patented COLLAMER lenses to Cruise Control, our unique new high vacuum surgery system, STAAR Surgical Company is responsible for some of the most revolutionary developments in ophthalmology. Main Job Responsibilities/Competencies Prepare and maintain 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval (PMA) applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II, III medical devices. Develop and maintain international regulatory submissions including technical files, registrations/licenses and design dossiers for CE marking, and those required for Canada and other international counties outside the US (OUS). Participate on product development teams from a regulatory perspective, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files. Review Notice of Document Changes (NDCs), Engineering Change Orders, and labeling, including assessments of regulatory impact. Maintain regulatory documentation, registrations and device listings both domestic and OUS. Review and interpret regulatory rules and ensure that they are communicated through company policies and procedures. Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies. Participate in compliance activities that relate to the department and the company as a whole. Write/revise departmental SOP's as required. May serve as a mentor for new employees and entry level staff. Perform additional duties as assigned by RA Director. Education & Training Bachelor of Science degree in a scientific related field Experience Minimum 3 to 5 years experience in Regulatory Affairs or related equivalent experience in the medical device industry required Class III medical device experience preferred Experience in ophthalmology desired Skills Thorough understanding of FDA and international regulations Strong working knowledge of medical devices regulations and terminologies Excellent written and oral communication, and technical writing and editing skills Ability to write clear, understandable technical documentation Skilled at analyzing and summarizing data Proficient with Microsoft Office Ability to manage and prioritize multiple projects Ability to follow written and verbal directions with a high level of accuracy Ability to work independently with minimal supervision Extreme attention to detail Ability to work in a team setting STAAR Surgical Company offers a comprehensive benefit package and a 9/80 Alternative Work Week Schedule. Please visit our website at www.staar.com

Job Title: REGULATORY AFFAIRS SPECIALIST I Company: Location: Skillman, NJ Description: Job Responsibilities: This position assists in the implementation of the ConvaTec Global Regulatory strategic plan to ensure timely filing and approval of new products and reregistrations and in providing Regulatory support to project teams. Responsibilities include working with the RA team and other departments to obtain datainformation in order to support and prepare filings for international registrations and tenders for medical devices, cosmetics, and overthecounter drugs, providing regulatory input on project teams for all global requirements and supporting assigned local markets in the Regulatory review of product labeling, advertising and promotional materials when necessary. Job Requirements/Education: Bachelors Degree in Science, Engineering or related technical field with 1 to 3years experience in the medical device, pharmaceutical, scientific, andor regulatory environment or the equivalent is desired. Familiarity with organizationalsystems, processes and products and a basic understanding of regulations in order to apply that knowledge when anticipating impact of regulatory decisions on the Regulatory organization and ConvaTec as a whole. Possessing some level of skill in document management and maintenance, including electronic document management systems and submissions is a plus. Qualified candidate will also possess strong people skills and be able to work with a range of culturally diverse people in supporting the registration filings. Also required are good organizational skills and the ability to plan, manage and execute projectbased tasks often with tight deadlines. It is expected that the candidate will also collaborate with associates from across the global QMRAEHS and other internal organizations and be comfortable in seeking informationsupport from industry or government sources. Salary will be commensurate with experience. Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D

Job Title: REGULATORY AFFAIRS TECH LEADER Company: Kimberly Clark Location: Neenah, WI Description: Kimberly-Clark, a global health and hygiene leader, and our trusted brands are an indispensable part of life for 1.3 billion people in more than 150 countries. Kimberly Clark has been helping generations of families improve the quality of their lives, to ensuring the health of our employees and the environment. We believe in recruiting the best people and putting them in the right jobs so that they can do their best work. Currently, we are seeking a GLOBAL REGULATORY AFFAIRS TECH Leader for our Neenah WI location. This position provides technical leadership in solving more challenging technical problems related to regulatory affairs issues and technologies. You will develop, initiate, and implement new regulatory affairs concepts, tools and strategies to improve business practices. You will also apply high level technical skills and expertise to complex quality systems and problems. This individual conceives designs and implements structures and programs to engineering projects. You will assist with the transfer of knowledge of technical skills and will be viewed as a Subject Matter Expert within the Regulatory Affairs organization. Previous international regulatory experience with product registration is required as well as Import/export experience across consumer goods, cosmetics and OTC drugs is required. Experience working with the Consumer Product Safety Commission is highly desired. A Bachelors Degree is required - Masters Degree is preferred and 7 � 10+ relevant experience is required. Send your resume today! E-mail (MS Word attachment): . Equal opportunity employer

Job Title: Clinical-Regulatory Affairs Specialist Company: Second Sight Location: Sylmar, CA Description: Are you an achiever? Are you confident in your ability and in your desire to make a difference? This most innovative company will allow your integrity and creative spirit to thrive as we strive to bring light back to blind individuals. Second Sight ( http://www.2-sight.com/ ) was founded in 1998 to develop, manufacture and market implantable visual prostheses to enable blind individuals to achieve greater independence. An FDA approved clinical trial of the first generation implant (Argus� 16) is ongoing and has enabled 6 blind subjects to detect when lights are on or off, describe an object�s motion, count discrete items, as well as locate and differentiate basic objects in an environment. We are currently conducting a clinical trial of the next generation Argus II retinal stimulator (with 60 independently controllable electrodes), which we hope will provide subjects with higher resolution images. Second Sight remains the only manufacturer with an actively powered permanently implantable retinal prosthesis under clinical study in the United States, and the technology represents the highest electrode count for such a device anywhere in the world. Further, Second Sight and its collaborators are actively engaged in the research and development of advanced arrays and systems that have the potential to provide higher levels of functional vision to subjects blinded by retinal degeneration. Second Sight is an environment that encourages capable individuals to govern their own work. It challenges them with difficult technical problems, fosters creative solutions and rewards people for their results. If such an environment appeals to you, come and be part of our team! Second Sight is searching for an experienced Clinical / Regulatory Affairs Specialist who is highly-motivated and detail-oriented. Responsibilities include: � Assists with the preparation of submissions for US and International regulatory agencies to gain approval s to conduct clinical trials and to request approval to market the company�s products � Maintenance of regulatory and clinical files including product catalog, complaint files, adverse events, and submissions � Provides support function for state, federal and notified body inspections of company�s operations � Prepares and updates product labeling that meets regulatory requirements � Assists with Safety Board oversight of clinical studies � Contributes to clinical and regulatory in-house procedure development � Implements complaint handling system and the returned goods authorization system � Provides assistance in product notification and recall activities � Works with cross functional teams to meet the company�s regulatory and clinical needs REQUIREMENTS: � Bachelor's degree required, preferably in Engineering, Physical or Biological Sciences � 2-3 years work experience, preferably in US regulatory affairs. Second Sight offers a competitive compensation package, excellent benefits and growth opportunities. We are an equal opportunity employer, committed to hiring a diverse workforce.

Job Title: Regulatory Affairs Specialist Company: Location: Houston, TX Description: In business for over a decade and leader in Scientific and Engineered Staffing, S&S Professional Services provides a wide variety of staffing solutions to companies in the greater Houston area. Our client, located in West Houston, TX, a petrochemical company, has an immediate opening for a Regulatory Affairs Specialist . The Regulatory Affairs Specialist will be responsible for the following duties: Will mainly process responses to customers in regards to questions of use of company products, specifically polymers. Will check legality of uses via TOSCA inventory Will look up regulation changes/updates made by the FDA on polymer products periodically. Will not provide any advocacy of the polymer products, just get customers compliant with FDA regulation and stay compliant. Will work with a world wide team so that project made be passed on for quicker turnaround on customer inquiriesWill also be required to determine reaction results of polymer with products that the customer says that the polymer will come in contact with. Will need to determine if a new product will then be produced from this reaction of if it will just create a blend. If a new product is formed then you advice company and customer where to go from there. Will be required to state how additives to the polymer will work and what uses they may have. Length of Assignment: Until the end of 2008, slight possibility of being taken on perm Start Date: July 1st at earliest Work Schedule: M-F 8am-5pm All interested applicants please submit salary requirements along with resumes.

Job Title: Regulatory Affairs Specialist Company: Location: Memphis, TN Description: Req. # 62400 Position Description SUMMARY: Responsible for the development and maintenance of Regulatory issues to include submissions, documentation, auditing functions and coordinating compliance projects in domestic and international arenas. This position works within the confines of the system, while moving into a more diverse scope and initiating new projects related to long-term growth. The Regulatory Affairs Associate II encompasses multiple functional areas with a concentration in one or more of these functional areas. Position Responsibilities ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Ensure compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements. Prepare required documentation (510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations. Attend design review meetings regarding design controls. Interacts with other departments to assist in determining the Regulatory pathways required for products that are in the development process. Research medical literature, regulatory documents and related information for inclusion into clinical articles and regulatory submissions and for evaluating manuscripts for accuracy, completeness, and adherence to regulatory requirements. Maintain department change control and compliance systems (ECR/ECN, CAR, etc.) Maintain systems for labeling, promotional material, change control and the documentation for these systems as required by domestic and foreign governments. Maintain database(s) for the worldwide regulatory status of company products. Complete and maintain company�s Medical Device Listing and Device Establishment registration forms. Handle regulatory related requests/questions from internal and external sources. Represent the company in issues related to legal and review agencies in support of regulatory requirements. Recognize and initiate projects related to long term product registrations or department growth / improvement. Maintain Regulatory department involvement and maintenance of information in company software and product databases. Basic Qualifications QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and EXPERIENCE REQUIREMENTS: Bachelor�s degree from an accredited college or university A minimum of two (2) to four (4) years of experience in domestic / International submissions, design controls systems and/or regulatory compliance. Desired/Preferred Qualifications Preferred: Degree preferably in a life sciences or technical field Experience with FDA requirements, ISO 9000, ISO 13485 and Medical Device Directive or other regulatory requirements preferred. OTHER SKILLS and ABILITIES: Superior interpersonal skills Excellent communication skills, both oral and written Proven ability to prioritize, conduct, and meet project deadlines. Documented evidence of writing skills Basic understanding of computer applications Familiarity with medical terminology a plus. Some overnight travel required. Physical Job Requirements PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job involve normal vision. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate.

Job Title: International Regulatory Affairs Specialist Company: Location: Southborough, MA Description: JOB DESCRIPTION JOB TITLE: International Regulatory Affairs Specialist DEPARTMENT (Name and Number): Regulatory FLSA/LABOR CODE: Exempt � Non-Exempt � Hourly � Direct Labor � Indirect Labor � REPORT TO: Vice President, Regulatory Affairs DIVISION/LOCATION: Corporate/Southborough JOB CODE/EEO CODE/JOB GRADE (To be completed by HR) PURPOSE/SUMMARY (Brief overview of why job exists, general purpose for position) Assist VP, Regulatory Affairs in obtaining approval to market Gyrus GYRUS ACMI, INC, Inc medical devices in the worldwide markets served by Gyrus GYRUS ACMI, INC, Inc. ESSENTIAL DUTIES AND RESPONSIBILITIES � Participate in product teams developing new products to define global regulatory requirements. � Review and approve product labelling and advertising. Work closely with Marketing in developing labelling materials. � Develop, coordinate, prepare and maintain US medical device submissions such 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed. � Develop, coordinate, prepare and maintain International medical device submissions such as EU design dossiers & technical files and Canadian Class 3/ 4 submissions and product registrations in markets such as Japan, the Far East, Australia and Latin America. Respond to regulatory authorities and/or distributor�s requests for additional information. � Interface with foreign distributors and international regulatory authorities and notified bodies as necessary to assure company products comply with country requirements. Work closely with International Marketing Department to implement company business plans. � Obtain Certificates of Product for Export or other applicable export notifications from FDA as needed. � Assist with the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. � Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. Advise regulatory management of changes and as appropriate communicate regulatory initiatives or changes to other GYRUS ACMI, INC staff. � Assist with the tracking of external standards applicable to company products and processes and maintenance of corporate standards library/index and communication of proposed/implemented changes to company staff. � As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes. Secondary responsibilities of this position include: Assist with compliance activities related to GMP and ISO regulations and ISO quality system standards. May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions. Assist Managers during quality inspections by FDA and International Regulatory Agencies. Responsible for responding to requests for information during inspections. Review product and process documentation for assigned projects to insure compliance with change control requirements and determining whether regulatory submissions are required. All Other Essential Duties as directed SUPERVISOR RESPONSIBILITIES (IF ANY) � Optional section (List of subordinate jobs for which this job has direct hire/discipline/budget responsibility) MINIMUM QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND/OR EXPERIENCE BS/BA required, preferably in engineering or life sciences. Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3-5 years preferred]. You must be able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel or Access, PowerPoint). CERTIFICATES, LICENSES, REGISTRATIONS ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES LANGUAGE SKILLS (verbal, written, listening), SOFTWARE SKILLS, ANALYTICAL SKILLS, PRESENTATION SKILLS, TEAM PLAYER, ETC. � Must be able to travel to Gyrus AMCI facilities in the US. The ideal candidates will have the following abilities: � Ability to work in small team environment, but also self-starter with ability to work independently. � Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors. � Must be able to meet deadlines and be detailed orientated. Good planning and organization skills a must. � Strong critical thinking and problem solving skills. � Documented continuing education in regulatory affairs and RAC Certified is a plus. PHYSICAL DEMANDS (e.g., expectations of such items as weight needed to move or lift) � Lifting/Carrying 50 lbs or more 2 hrs a day � Bend/Stoop/Kneel 2 hrs a day � Push/Pull 50+ lbs 2 hrs a day � Microscope/fine close work ___ a day X Stand/Sit/Walk 8 hrs a day � Dexterity required � Vision requirements ____________ � Operate moving vehicles � Other: Gyrus GYRUS ACMI, INC, Inc. is an Equal Opportunity/Affirmative Action Employer