Director Of Regulatory Affairs Jobs

Job Title: Director of Regulatory Affairs BHJOB1778_219 Company: Medical Devices & Diagnostics Company Location: Cambridge, MA Description: The Wellington Group is seeking an experienced regulatory affairs professional for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market! The Director of Regulatory Affairs is a key role in the development, research and commercialization of new products and the management of regulatory and quality disciplines for the organization. The Director will ensure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products. Responsibilities include: • Lead a team of regulatory professionals to define and implement the regulatory strategy • Lead the preparation, submission, and timely approval of regulatory applications • Lead the interaction and negotiations with regulatory agencies • Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products • Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends The qualified candidate will have: • 10+ years of Regulatory Affairs experience with at least 4 years of medical devices and 4 years in senior manager • 4-year degree required, graduated degree preferred • Experience in providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products • Experience in preparing and obtaining approval of device/drug combination products • FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications • Significant experience planning for and management of regulatory compliance audits Industry: Medical Devices, Biologics, Pharmaceutical Location: Either RTP, NC or Cambridge, MA Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance. Don’t wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group

Job Title: Manager of Regulatory Affairs-Medical Devices Company: MRINetwork Location: Indianapolis, IN Description: Regulatory Affairs ManagerLocation:Indianapolis, INDescription:Our client is a medical device company focusing on orthopedic products and service that repair, replace and regenerate.Opportunity Statement:This position will be responsible for managing all facets of regulatory support to market our client’s products.Qualifications & Characteristics:Bachelors level degree in a scientific related field 6 years of experience in a Regulatory Affairs capacity Regulatory Certification preferred Experience in pharmaceuticals/biologics and combination drug/device products is a plus Ability to travel up to 20% of the time Strong knowledge of US FDA and EU regulations is required Strong writing and communication skills Experience managing others Passion, energy, personal drive, and motivation Responsibilities:·        Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the FDA regulatory submissions process.  May author and publish electronic submissions·         Manages the development of dossiers for registration of products in countries outside the US.  Oversees the authorship and publication of electronic submissions·         Assigns RA professionals to serve on development project teams as core team members; communicates regulatory strategy for new products·         Keeps all areas internally informed of regulatory requirements and emerging issues which may affect the registration approval of products.·         Communicates with Regulatory agencies.·         Responsibility for oversight and prioritization of departmental tasks and projects.·         Directs and oversees the work of regulatory professionals, including training, mentoring and insuring professional development.·         Interprets and applies FDA regulations to business practices and provides regulatory input, advice and guidance to the organization·         Responsible for interacting with governmental agencies·         Establishes RA policies and procedures and ensures compliance with themWe will only be able to respond to those inquires who meet the stated requirements.  Please include the position ID "CC-1620" in the subject line of your correspondence.  Please forward your credentials in confidence to: Register to View (Word format please) To review additional opportunities, please visit our website at: www.ccesearch.com

Job Title: Regulatory Affairs Manager - Company: Location: San Diego, CA Description: Scantibodies Laboratory, Inc., one of the largest Biotech comapnies in San Diego is currently recruiting for a Manager of Regualtory Affairs. Description: Ensure that Scantibodies obtains and maintains all regulatory approvals of products and facilities. This person is a key driver of change within Scantibodies and is heavily focused on Improvements to products and processes. Experience must include 510K filings for in-vitro diagnostic devices or medical devises, Submission of pre-IND, IND, NDA/BLA applications for drugs and biologics, developing a regulatory strategy for the regulated products which ensures compliance with regulations and marketability of products. Management of Department personnel. Requirements: Bachelors Degree, minimum of 7 years experience in regulatory affairs in similar industry, knowledge of GMP/QSR and ISO international regulations and standards which apply to SLI. Computer literate in MS Word and Excel and possess excellent communication skills. Benefits Include: Medical, Dental, 401K with company match, tuition reimbursement and incentive compensation. visit our website at: www.scantibodies.com

Job Title: Director of Regulatory Affairs & Quality Assurance Company: LABS, Inc. Location: Centennial, CO Description: Employer Information About LABS, Inc. Regulated testing laboratory View all our jobs Job Under administrative direction, assists company with the development, implementation, management and continual improvement of an effective quality assurance program. Serve as a regulatory resource to the organization by providing input and opinions that are in compliance with applicable rules and regulations. Manage and drive systems to closure that are already established with the quality program. Serve as a role model for company values and culture, consultant for internal/external customers on compliance and regulatory issues. This position will supervise the Quality and Regulatory Staff and will become a part of the Executive Leadership team. NOTES: Local Country Candidates Only. Additional Salary Information: Salary depending on experience. Bonus plan.

Job Title: Senior Director Regulatory Affairs Company: Celera Location: Alameda, CA Description: CDRH, PMA, IDE, 510(k), CBER, FDA Submissions Senior Director Regulatory AffairsLocation: Alameda - Harbor BayEmployment Status: Full-time RegularSummary: Celera is a healthcare business that uses knowledge of human variability to provide new tests and services to personalize disease management. Our Products business develops and manufactures molecular diagnostic products. Our Services business, Berkeley HeartLab, Inc. (BHL), is a high complexity CLIA certified laboratory that offers over 25 clinical diagnostic tests. And our 4myheart centers are staffed with medical professionals who use results from testing at BHL to work with patients, under their physician’s direction, to develop customized regimens for exercise, nutrition, stress management and therapy compliance. Supporting these businesses, our internal research and partnering activities fuel the development of new diagnostic tests for personalizing disease management in our products and/or services. For more information about Celera, please visit us at www.celera.comBASIC FUNCTION AND SCOPE OF THE POSITION:Directs, plans and manages a department function that executes strategies to market new innovative diagnostic devices which meet governmental requirements in the US and the rest of the world. Creates submissions that are clear and concise to achieve regulatory clearance/approvals in minimal time frames. Encourages, develops, edits and reviews departmental and/or investigator publications in support of Celera products. Review and approval of clinical strategies and protocols as related to submissions. Accountable for ensuring that Celera product labeling is compliant with all domestic and international labeling regulatory requirements. Directs the activities of domestic and international submission experts both internally and externally. Provides expert advise to executive management and technical personnel regarding domestic and international submissions requirements and strategies. Takes the lead on routine interactions with the FDA and international authorities on submission matters. Liaison with marketing and sales force for appropriate advertising and promotional activities. IMPACT:Successful performance contributes to receipt of and maintenance of regulatory approval for Celera products. Decisions would affect the financial, employee, or public relations posture of the company. Erroneous decisions or recommendations would result in failure of the overall success of the function, division or company operations.ESSENTIAL JOB DUTIES: • Responsible for supervision of direct reports which includes interviewing, hiring, training, goal setting, evaluating performance, prioritization of work, salary administration, career development, and compliance with personnel, financial and safety policies. Represents the department to other groups in the company.• Directs preparation of all required submissions to regulatory bodies, licenses and certificates to allow Celera products to be legally marketed.• Ensures that pre-clinical development is commensurate with regulatory requirements and product claims.• Review and approval of clinical strategies and protocols as related to submissions.• Develops and manages high-performance teams including outside resources. • Maintains expertise for international governmental regulatory marketing requirements such as ISO, CE, Canadian Medical Device, etc. • Ensures appropriate Regulatory Plans for product development teams.• Encourages investigators to publish data to support Celera products through building relationships with external research collaborators and development partners. • Develops and maintains budgets to support regulatory submissions, licenses and other RA activities. • Provides recommendations on product approval status and actions to be taken to achieve the objectives of the business plan.• Manages direct reports for assigned projects and acts as backup for department head.• Prepares regulatory Letters to File and product update reports, as necessary.• Ensures appropriate statistical analyses are applied to data that support product claims.• Reviews product label copy, promotional and advertising materials and manuscripts for publication.• Manages the Regulatory Affairs staff including recommendations and justifications for staffing and training needs. • Establishes departmental goals and objectives in support of meeting the business plans.QUALIFICATION REQUIREMENTS:To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EDUCATION AND/OR EXPERIENCE:B.S. degree in a scientific field with at least twelve (12) years of postgraduate industrial experience with at least seven (7) of those years in industrial diagnostic clinical trial and regulatory submission experience. Must have at t least five (5) years experience managing a Regulatory department at a Sr. Manager/Director level. FDA Advisory committee experience preferred.LANGUAGE SKILLS:Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the scientific community. Ability to write publications that conform to prescribed style and format.MATHEMATICAL SKILLS:Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of science or engineering and algebra. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.REASONING ABILITY:Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.LICENSES, CERTIFICATES, REGISTRATION:None.OTHER KNOWLEDGE, SKILLS AND ABILITIES:Must possess excellent command of the English language and demonstrated proficiency in written and oral communications. Computer skills with basic workplace software such as Word and Excel are required. CDRH experience with PMA submissions and approvals, 510(k) submissions and approvals and/or IDE submissions are a requirement. CBER submissions experience is a desirable. He/she must demonstrate the creative ability to develop and apply new skills and creative approaches to a myriad of complex problems. His/her primary function is to solve problems, which are highly complex and require very knowledgeable and sophisticated regulatory, clinical, statistical, chemical, biological and business approaches for effective resolution. The Director must be able to work effectively within technical groups involving many other disciplines. A high degree of technical expertise and the demonstrated ability to apply this expertise the regulatory submissions is required. Must be able to understand the “moving bar” of FDA submissions requirements and be comfortable in interpreting FDA submission guidance documents and international standards. Must be able to assess and communicate degrees of risk as part of regulatory submissions recommendations. The Director must understand current FDA regulations, guidelines, thinking, concepts of regulatory strategies and requirements to deal with the broad problems and issues involved in regulatory submission activities. He/she must have in-depth knowledge and understanding of the chemistry, biology manufacturing processes and quality sciences relating to the products and processes. Project management skills are essential to enable efficient planning and execution of submission time lines. Must have strong technical and analy

Job Title: Sr. Regulatory Affairs Manager Company: MedFocus Pharm. Res.Opp. Location: Chesterbrook, PA Description: REGULATORY AFFAIRS MANAGER/SENIOR MANAGERCOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client focuses its business on attention deficit and hyperactivity disorder, human genetic therapies and gastrointestinal diseases and is seeking to add a Regulatory Affairs Manager/Senior Manager to their team in Chesterbrook, PA.RESPONSIBILITIES:•    Offers strategic and operational regulatory support to preclinical, clinical, manufacturing, quality assurance and marketing departments.•    In collaboration with management, develops and reviews regulatory strategy for operational efficiency.•    Negotiates and makes agreements on behalf of the department.•    Interprets applicable regulations and guidelines for project team use.  Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations.•    Provide regulatory review of promotional materials and ensure compliance with federal regulations and corporate SOPs.•    Responsible for investigational and post-approval submissions associated project, including safety reporting, CMC, and labeling responsibilities.•    Ensures timely submission of appropriate regulatory documents individually, as a regulatory team, or through contract organizations.•    Coordinates and solicits components of the submission from various functional areas.•    Raises major project issues to management for resolution and agreement.  •    Work efficiently and effectively within regulatory team, fostering collaborative exchanges, teamwork, and mentoring of colleagues. •    Attends company advisory panel meetings, investigator meetings and kick-off meetings as required.•    Mentors other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.•    Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.•    Complexity and Problem Solving•    Decisions on regulatory strategy are to be made by this individual.  Decisions of significant strategic impact must be discussed to supervisor.•    Position is accountable to supervisor.  Internal contacts may include PST members, BU representatives, R&D functional representatives, Legal, Supply Chain, and Program Management.  External contacts may include health authorities, vendors, and consultants retained by company•    Some domestic and potential international travel required.QUALIFICATIONS:•    Bachelor’s degree is required. Scientific/health care field preferred, but not required. •    Generally has at least 7 years of related experience within a pharmaceutical company, CRO or similar organization and at least 2 years of management experience; or equivalent combination of education and experience.  •    Generally has at least 4 years direct regulatory affairs experience.•    Must have experience in drug promotional review, including consumer and professional venues.•    Must be able to communicate comfortably and effectively with regulatory authorities.•    Must have extensive experience effectively working in team environment. •    Ability to work successfully within a cross-functional team.•    Must be able to independently present complex information to copmany senior management, CROs, regulatory authorities and the medical community.•    Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.  •    Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. •    Ability to work independently, take initiative and complete tasks to deadlines.•    Proven ability to independently resolve problems. •    Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook.MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

Job Title: Associate Director Regulatory Affairs - CMC Company: Top Echelon Network Location: Foster City, CA Description: Reporting to the Head of CMC Regulatory Affairs this person will responsible for leading regulatory activities for assigned projects.They will prepare submissions that are technically complex. This requires extensive interaction with departments outside of Regulatory Affairs. They will be responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned products.This person must hold a scientific degree and have at least 10 years in progressive experience in Regulatory Affairs. An advanced degree is preferred. Director people management and experience as the Regulatory representative on project teams is required. This person needs to fully understand the regulatory process and be able to suggest and support changes to the system.   See all jobs in Foster City CA

Job Title: REGULATORY AFFAIRS MANAGER – (medical devices) Company: Carestream Health Location: Rochester, NY Description: Employer Information About Carestream Health Carestream Health, Inc., formerly Eastman Kodak Company’s Health Imaging Business is an internationally recognized provider of medical and dental imaging systems, healthcare information solutions; molecular imaging systems; and non-destructive products. ONEX, one of Canada’s largest corporations, acquired the Eastman Kodak’s Health Imaging Division in a multi-billion-dollar transaction in May 2007. Upon closing, the business began operating as Carestream Health, Inc., an independent subsidiar....more info Job The Regulatory Affairs Department at Carestream Health is a division of the Corporate Technology Office. Activities are dedicated in support of product development and commercialization and post-market surveillance including adverse event reporting, international product registrations and oversight for medical device recalls. Our portfolio includes Class I, II and III devices some of which are exempt from premarket notification while others are PMA devices. Reporting to the CTO Regulatory Affairs, The Regulatory Affairs Manager provides post-commercialization and post-market regulatory support to Carestream medical device products both domestically and internationally. This includes regulatory support for current product engineering, manufacturing, servicing and post-market surveillance activities. The Regulatory Affairs Manager will be required to prepare product files for submission for Class I, Class II medical devices and compliance to domestic and international governments to obtain approval to market medical devices. The Regulatory Affairs Department offers you the opportunity to work in a very innovative and exciting environment where you will be exposed to and challenged with a broad spectrum of product submissions and global regulatory requirements. For the candidate who desires to continually develop and hone their regulatory skills this is a great job! This is a full-time, regular position, not a consulting role. Carestream Health offers very competitive compensation including excellent employee benefits and a great work environment. You must be authorized to work in the United States; company sponsored immigration is not offered. Relocation assistance is available for qualified candidates. Primary Responsibilities Assist in preparation of post-marketing approval applications, such as Pre-Market Application (PMA) Supplements. Communicates with commercialization Regulatory Affairs manager regarding Product Hazard Risk Management, significant post-launch design changes etc. Prepares license amendments and annual reports to Therapeutic Directorate of Health Canada regarding Class 1 and Class 2 medical devices Provides documents supporting international product registrations, approvals or licenses for additional marketing approvals after product launch. Proficient with, communicates and verifies compliance with new regulatory requirements that impact product that is on the market Works closely with cross-functional teams and individuals in providing regulatory oversight for post-launch product development activities and updates post-commercialization deliverables such as the Declaration of Conformity, Technical Construction File, etc. Works with current product engineering/manufacturing staff to review and approve product modifications, including engineering change orders, drawings, test plans & reports, field manual or parts list updates or supplier certifications Participates in Corrective Action Teams post-launch. Reviews and approves all post-launch customer publications, labels, labeling and marketing advertising and/or promotional materials for products marketed by the company. Responsible for coordination, documentation and submission of Medical Device reportable events. Provides training on applicable medical device regulations. Owns Regulatory Affairs Standard Operating Procedures processes that apply. (i.e. Post Market Surveillance, EMDR Process, Electronic Radiation Report, etc.) Participates in product quality investigations and Regulatory Agency inspections including internal and external audits Functions as a product line expert within Regulatory Affairs. Provides guidance and support to QA and QE for post market adherence to GMPs, QSRs, and GCPs. To apply for this position, please visit the careers section of our website at www.carestreamhealth.com and insert “999BR” into the search field. Carestream Health is an Equal Opportunity Employer. NOTES: Employer will assist with relocation costs

Job Title: Manager, Regulatory Affairs Company: Boston Scientific Location: Boston, MA Description: Manager, Regulatory AffairsRequisition ID 31473Full/Part Time xLocationMarlboroughMADescriptionSummary:Responsible for multiple product lines, technologies and specialized functions. Devotes a significant portion of time to managerial, leadership and employee development responsibilities.Responsibilities:Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team.Provides day to day management of Regulatory Affairs function for major divisional business segment.Establishes project priorities, allocating resources and workload.Provides technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies.Reviews and edits submissions prepared by staff.Represents Regulatory Affairs at management updates.Provides long range strategy formulation.Develops and implements departmental policy and procedures.Provides Regulatory Affairs training/mentoring to other employees.Support and maintain quality initiatives in accordance with BSC Quality Policy.Continuously assess ways to improve Quality.Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.Develops and implements regulatory strategies for new and modified products.Oversees preparation and submission of global regulatory applications as well as internal regulatory file documentation.Oversees review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.Supports highly technical or major business segment product lines, special projects and strategic initiatives.Qualifications:Bachelor s degree or equivalent work experience, preferably in a scientific or technical discipline.Professional certification(s) preferred.9 plus years Regulatory Affairs medical industry experience preferred.5 plus years managerial/supervisory experience preferred.Overall understanding of global regulations.Strong technical knowledge of medical products.Comprehensive understanding of relevant medical procedures, practices, terminology, and products.Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.Thorough knowledge of product development process and design control.Excellent research and analytical skills.Excellent written and oral communication, technical writing and editing skills.Ability to effectively manage multiple projects.Strong organizational, leadership, interpersonal and influencing skills.Proficiency with Microsoft Office.Working Conditions:General office environment, with potential (domestic and international) travel to BSC facilities and other meetings

Job Title: Director Regulatory Affairs Company: Office of the Secretary for Human Resources & Admin Location: Washington, DC Description: This position is located in the Office of Legislative, Regulatory, and Intergovernmental Affairs which, among other programs is responsible for monitoring all Congressional legislation that affects the Veterans Health Administration. You will act as advisor to the office executive responsible for one or more major, mission-oriented agency functions or programs. ·         Serves as senior advisor and strategist to the executive on one or more substantive mission-oriented functions or programs. Reviews proposed legislation for impact on current programs, policies, and operations; coordinates and helps to draft regulations to implement new or revised legislation; develops and implements new program initiatives; and develops measurement criteria for evaluating program performance and effectiveness. Assesses the impact of issues and provides objective, independent assessments and recommendations for strategies or policy changes. ·         Leads project and study teams in developing and implementing program initiatives and evaluating program performance. Ensures coordination with and involvement of representatives of other agency organizations, other agencies, and private sector entities with an interest in or relationship to the program. ·         Serves as liaison and representative of the executive within the agency and with outside parties in assigned functional or program areas. Attends conferences, meetings, and hearings on the executive’s behalf and keeps the executive informed of potential issues and problems. Serves as a member of committees and project teams related to assigned functional or program areas. ***RELOCATION EXPENSES AND/OR INCENTIVES ARE NOT AUTHORIZED***