Director Of Regulatory Affairs Jobs in California

Job Title: Paying up to $115k for a Director of Regulatory Affairs Company: AppleOne Location: Irvine, CA Description: Job Description:A well-established company in Irvine, CA is in need of a Director of Regulatory Affairs. This company makes diagnostic kits. This person must have the following experience:At least 3-4 years stability in past positionsA minimum of 5 years experience working as a Director of Regulatory Affairs. This person MUST have experience working in the medical device industry. A degree in biology, bio-chem, or immunology is preferredAlso must have extensive experience with 510K submissions and FDA Understand the antigen cells and antibodies. Knowledge of 510 K clearances Must have knowledge and experience with ISO 13485 If you have the qualifications please call Liliana. You can view all of our jobs online at http://www.appleone.com/?sc=11&id=475918 Job Experience:Director of Regulatory Affairs, medical device industry, biology background, FDA

Job Title: Director of Regulatory Affairs Company: TEKsystems Location: Irvine, CA Description: Company: Teksystems Position Title:Director of Regulatory Affairs Job Code:2045802 Job Location: Irvine, California Description:Director of Regulatory Affairs Job Description: Aerotek Scientific is currently searching for a Director of Regulatory Affairs with at least 7 years in CMC product development experience.Requirements:- 7 years experience in Regulatory Affairs, specializing in Chemistry, Manufacturing &/or Clinical Product Development.- Experience with IND, NDA, CTX and MAA submissions and registration activities/compliance functions.- Previous experience working with cross-functional development teams, CRO's and international regulatory agencies.-BS or MS in Pharmaceutical Chemistry, Biology with a minimum of 7 - 10 years in regulatory affairs and RAC. Required Skills for Director of Regulatory Affairs Job: *REGULATORY AFFAIRS * REGULATORY CMC * DIRECTOR LEVEL * IND * NDA * GXP About Aerotek Scientific: Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Contact Information Amy Nguyen Apply Now! Begin by filling out the "Apply Online for this Job" section at the top of the page Need Directions? Get office driving directions with Google Maps Register to View Aerotek Scientific-Orange County II, CA 1971 East 4th Street Suite 130 Santa Ana, CA 92705 TEL: Register to View TEL: Register to View x2114 FAX Register to View

Job Title: Director, Regulatory Affairs Company: CareFusion Location: San Diego, CA Description: JOB TITLE: Director, Regulatory AffairsEvery day at CareFusion, we work to improve patient care. By combining clinically proven products and services with actionable intelligence, we're helping to solve some of healthcare's most difficult challenges. Join us.Function: QRAFamily: Reg Affairs - Regulation DevWhat Reg Affairs - Regulation Dev contributes to CareFusionRegulatory Affairs-Regulation Development is responsible for planning, coordinating and implementing regulatory strategies for lobbying various regulatory agencies on issues germane to CareFusion. What is expected of you and others at this level in Quality & Regulatory Affairs for functional success Provides leadership to Managers (M2); may also manage first-line supervisors and/or professional staffDevelops financial and operational objectivesEnsures operational plans are aligned with business objectivesContributes to functional strategy developmentHas in-depth functional expertise and broad business knowledgeApplies expertise to achieve financial and operational objectivesMakes decisions, often difficult and/or unpopular, that support the organization strategy; influences others to support the decisionsRole models CareFusion's high ethical standards and code of conductCreates challenging roles and responsibilities to build organization capabilities and fill capability gapsImplements succession plan for managing talent within and from outside the organizationSets goals for the function/ work area that are aligned with function/organization goalsInspires others to meet/exceed expectations on a daily basis through own enthusiasm and energyIdentifies and initiates efforts to achieve objectives, teaching others to accept accountability for meeting and stretching to exceed results in a timely and cost effective mannerManages resources to ensure financial objectives are met, leveraging knowledge of competitive advantage and profit driversAnticipates internal/external business issues to align operational priorities, strategies and tacticsConstructs meaningful strategies for addressing future business scenariosDevelops relationships with key internal/external customers to identify emerging needs and business challengesDevelops value-added solutions that meet customer business needs and shares key learnings with othersResolves complex problemsRecognizes and rewards innovative thinking, responsible risk taking and the achievement of operational excellenceDevelops broad influence through a robust set of internal/external relationships across the organization; promotes win-win outcomes within, among and across teams, using the diverse perspectives of others to achieve resultsInfluences customer and/or organizational leadership through effective listening and communication to accomplish operational objectives Accountabilities in this roleThe Director of Regulatory Affairs is responsible for CareFusion-wide regulatory compliance and escalation support, regulatory development of industry standards and regulations and conducting and supporting regulatory reviews and common tools. Principal accountabilities include: 1. Managing Corporate Audit activities and three Corporate Auditors2. Perform audits and regulatory preapproval submissions as required for CareFusion facilities and operations3. Providing audit reporting with the senior management of CareFusion4. Working directly with the different CareFusion businesses on business claims and communications review5. Coordinating any Ethics and Compliance product quality escalations6. Developing and rolling out business-enabling regulatory affairs tools and systems7. Representing CareFusion Regulatory Affairs at applicable industry groups8. Knowledge of FDA Medical Device Regulation,  ISO 13485 Medical Device standard is required and experience with ISO 14971 Risk Management standard is preferredQualifications Bachelor's degree required, advanced degree preferred6-10 years experience5-7 years of management experience strongly recommendedStrong leadership skills requiredStrong communication skills required Additional Information:Travel Percentage: 15%

Job Title: Director Regulatory Affairs for dynamic Medical Device Leader Company: Advanced Bionics Corporation Location: Valencia, CA Description: A. Primary FunctionManage the regulatory affairs function. Generate or direct regulatory affairs specialists in the preparation of submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwideB. Duties and Responsibilities1. Generate or direct regulatory affairs staff in the preparation of submissions (i.e. PMA, 510(k), CE marking applications, production registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Product subsequent submissions (annual reports, PMA Supplements, change notifications, etc.) to facilitate the maintenance of these approvals. Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals.2. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e. IDE) for conducting clinical investigations in U.S., Canada, and EU countries. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies. Oversee the required submissions (progress reports, etc.) to support the continuation of clinical studies3. Responsible for issue/complaint handling system. Ensure that all reports and information required by complaint reporting and postmarket vigilance systems are maintained and submitted.4. Provide input to the engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development design.5. Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes.: PQRB, PIR/Field Action, RLT, CAPA, Change Board, Management Review, and Risk Management. Assess and initiate regulatory filings where needed.6. Review and provide input to labeling and marketing programs in reference to regulatory requirements.7. Keep abreast of new or developments in various regulations and advice senior management as necessary.8.  Interface with regulatory agency representatives as needed to accomplish the above tasks.9. Other duties as assigned. C. Specialized Knowledge & Skills1. Good working knowledge of U.S. FDA, Canada and EU regulations and standards.2. Excellent interpersonal, communication (oral and written), team work, leadership, organizational and negotiating skills3. RA certification (by Regulatory Affairs Professional Society) is a plus.D. Experience10 - 15 years of experience in the area of worldwide regulatory affairs (both submissions and compliance) at medical device companies, preferably under the Class III/active implantable device manufacturing environment. Must have supervisory experience of professionals.E. Education & TrainingB.S. in scientific discipline or engineering or equivalent.

Job Title: Director of Regulatory Affairs Company: Advanced Bionics Location: Valencia, CA Description: Employer Information About Advanced Bionics Advanced Bionics® Corporation is a global leader in developing the most reliable, best performing cochlear implant devices in the world. Founded in 1993, AB is the only American company developing cutting-edge cochlear implant technology that restores hearing to the deaf and allows our recipients to hear their best today, tomorrow, and always. We support patients, clinicians, and physicians through the latest scientific research, technology development, educational resources, attentive customer ....more info View all our jobs Job A. Primary Function Manage the regulatory affairs function. Generate or direct regulatory affairs specialists in the preparation of submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide B. Duties and Responsibilities 1. Generate or direct regulatory affairs staff in the preparation of submissions (i.e. PMA, 510(k), CE marking applications, production registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Product subsequent submissions (annual reports, PMA Supplements, change notifications, etc.) to facilitate the maintenance of these approvals. Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals. 2. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e. IDE) for conducting clinical investigations in U.S., Canada, and EU countries. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies. Oversee the required submissions (progress reports, etc.) to support the continuation of clinical studies 3. Responsible for issue/complaint handling system. Ensure that all reports and information required by complaint reporting and postmarket vigilance systems are maintained and submitted. 4. Provide input to the engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development design. 5. Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes.: PQRB, PIR/Field Action, RLT, CAPA, Change Board, Management Review, and Risk Management. Assess and initiate regulatory filings where needed. 6. Review and provide input to labeling and marketing programs in reference to regulatory requirements. 7. Keep abreast of new or developments in various regulations and advice senior management as necessary. 8. Interface with regulatory agency representatives as needed to accomplish the above tasks. 9. Other duties as assigned. NOTES: Local Country Candidates Only. Additional Salary Information: Salary commensurate with experience.

Job Title: Director of Regulatory Affairs/Quality Assurance Company: Location: San Diego, CA Description: Aubrey Inc. (www.AubreyInc.com) is a new bioengineered wound dressing manufacturer that is looking for a Director of Regulatory Affairs/Quality Assurance. Our Ideal candidate must have superior time management abilities, great attention to detail and the ability to multi-task in a fast-paced environment. Position Summary: Assure that the company has effective systems and programs which result in compliance with all applicable medical device regulations and standards. Determine organizational objectives and Quality System updates required to both support and promote continued aggressive growth in a compliant and cost-effective manner. Duties and Responsibilities: ? Responsible for regulatory compliance with: FDA, ISO, CMDR, Notified Bodies, and foreign regulations. ? Serves as the Quality and Regulatory authority to the company as required. ? Responsible for interactions and negotiations with applicable regulating agencies and business partners regarding product compliance, both domestically and internationally. ? Responsible for the creation and maintenance of regulatory submissions within and outside of the United States. ? Management Representative responsible for implementing and maintaining a compliant Quality System per FDA and ISO requirements; represents company during medical device regulatory agency audits and inspections. ? Responsible for assuring compliance of products manufactured. ? Assuring quality system requirements are met and distribution requirements are maintained to meet corporate business goals and objectives. ? Promote organization's growth and adherence to industry standards in regard to product assurance, validations, design controls, document and data controls, supplier management, statistical techniques, etc. This includes overseeing the technical review and approval of individual scientific and engineering protocols and reports as well as the identification of next-generation Quality System methods and toolsets. ? Oversee the Quality Assurance function with the independence and authority to ensure quality processes and products. ? Oversee internal quality system audits, supplier quality audits, due diligent audits. ? Responsible for department budget and adherence to business plan, goals and objectives. ? Provide support with compliance and quality assurance decisions as needed to: QA, Operations, R&D, Sales and Marketing, Clinical Affairs and Executive Management. ? Responsible for corporate deliverables, as required. Qualifications: ? Bachelor?s degree from a four-year, accredited college or University. Bachelors of Science in Engineering or Life Science. ? Fifteen years experience in a medical device or biotechnology company in the capacity of Regulatory and/or Quality Assurance function. ? Knowledge and direct working experience with ISO 13485, FDA GMP?s, MDD and CMDR regulations. ? Experience working and negotiating with regulatory agencies serving as the company liaison. ? Experienced directing activities for obtaining PMA, 510K and CE mark approvals. ? Good teamwork and interpersonal skills, good communication and presentation skills, English communication skills Application Process: ? Email a cover letter including salary requirements and your résumé to Register to View Candidates that do not include salary requirements will not be considered.

Job Title: Associate Director Regulatory Affairs - CMC Company: 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.

Job Title: Director Regulatory Affairs - Medical Device, 510(k), PMAs, IDEs Company: CyberCoders Location: Dublin, CA Description: Director Regulatory Affairs - Medical Device, 510(k), PMAs, IDEs, International RA, New Product RAIf you are a Director Regulatory Affairs with Global experience, please read on!We are currently hiring 2 Directors for Regulatory Affairs, one focused on New Products and the other on International Submissions. Director of Regulatory Affairs Requirements:- RAC Certification- Domestic and International Medical Device Standards: CFRs, MDD, MHLW, CMDR, TGANew Product, Regulatory Affairs Director will:- Develop Regulatory strategies for new products, interact with International Regulatory Authorities, prepare Technical Files and Design Dossiers, 510(k), PMA (Premarket Approval), IDE (Investigational Device Exemptions).- Develop and oversee Regulatory Clinical Trials, Clinical Study Protocols.International, Regulatory Affairs Director will:- Interact with International Regulatory Authorities, prepare Technical Files and Design Dossiers, 510(k), PMA (Premarket Approval), IDE (Investigational Device Exemptions).- Maintain Global Registration database, documents and master list, Vigilance, Complaint Reporting, etc.So, if you are a Director Regulatory Affairs looking to join and established, growing company, please apply today!Must be authorized to work in the United States on a full-time basis for any employer.

Job Title: Manager, Regulatory Affairs Company: Nektar Therapeutics Location: San Carlos, CA Description: Position Summary Responsible for supporting the Regulatory department across a number of company-sponsored projects. Primarily responsible for assembling and reviewing regulatory dossiers prior to review by senior regulatory management. May select, develop, and evaluate personnel to ensure the efficient operation of the function. Responsibilities Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems. Supports regulatory filings and registrations by coordinating, assembling, preparing and editing for review regulatory document packages in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.) Prepares information for, review and ensures that submissions meet format and content requirements applicable for regulatory requirements (i.e., US, ICH). Reviews specifications, methods, SOPs, protocols, reports, labeling, and etc... for regulatory compliance. Maintain regulatory submissions and correspondence for company-sponsored projects, and all company-related sections for partner-sponsored projects. Drafts and reviews Regulatory Affairs' SOPs. May participate in, and provide regulatory guidance to working teams (both internal and partnered programs). Supports other projects as needed, which will include but not be limited to performing research and compiling materials to develop regulatory strategies.Works with department management to provide input on timelines for submissions. Solves problems of moderate levels of complexity following established company policies and procedures. Follows general instructions to complete projects. Organizes workday to complete mid-term assignments. Capable of working independently to complete mid-level assigned projects. May be responsible for conducting performance reviews and providing feedback and coaching to direct reports.

Job Title: Mgr. Regulatory Affairs (216852-052) Company: Not Specified Location: Los Angeles, CA Description: 216852-052 Job Description Regulatory Affairs Manager  Grifols has been a leader in the healthcare industry since 1940 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed product designed to improve human health. At its Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. The Grifols family of companies, including Grifols Inc., Grifols USA, Grifols Biologicals, Biomat USA and Plasma Collection Center, Inc. For more information, please visit our website: http://www.grifolsusa.com/.  Grifols Inc. is the company that sets the corporate policies of all Grifols companies in the US (Grifols Biologicals, Biomat USA and Grifols USA). Also, it provides shared services on Human Resources, Information Technologies, Accounts Payables, Controlling, Audits, Planning and Finance and Regulatory Affairs. This company has an immediate opening for a Regulatory Affairs Manager offering an excellent benefits package, including medical, dental, vision, 401(K) plan, life insurance, educational assistance, and generous paid time off. Position Summary: Reports to the Regulatory Affairs (RA) Director.  Incumbent must have excellent written and verbal communication skills, be well-organized, very detail-oriented, and be able to multi-task.  The incumbent must be able to interact effectively within project teams to achieve group goals; and must have the ability to withstand pressure when work priorities change and/or timelines accelerate. The position requires negotiation of project completion timelines with internal commercial and external project leaders.  Position requires continuous scheduling of activities and projects as demands and target dates change. Job Responsibilities:  (This job description is accurate at the date of publication and may change over time.  It is not intended as an exhaustive description of the job.  Other duties may be assigned and qualifications required may change.) Responsible for the planning, review and preparation of In Vitro Diagnostics (IVD) documents for pre-IDEs, premarket notification or 510(k), and BLA submissions to the CDRH, CBER, U.S. FDA.  Review IVD performance studies for autoanalyzers and other clinical automation and analysis instrumentation, and diagnostic test kits related to immunology, blood banking, hemostasis and clinical diagnostic test kits in general.   Be familiar with FDA-required standards, e.g., EP-A2, EP6-A, EP7-A2, EP9-A2, EP17-A. Review FDA IVD guidance documents and update management of changes in the regulatory requirements which will impact the company. Project planning – write project plans with target due dates to complete milestones.  Monitor changes, inform relevant parties involved.  Solve problems, take actions as required, and work in an efficient manner to ensure milestones are met by target dates. Represent the department in meetings, both regulatory and commercial in nature. Interact effectively with quality, regulatory, research personnel within the company, internal business managers and external suppliers/distributors in order to complete projects in a timely manner. Prepare electronic 510(k) submissions. Train personnel and write regulatory SOPs.   Required Experience Required Skills, Experience & Education:  (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). Mimimum of B.S. degree required. 5 years minimum experience in regulatory submissions in the in vitro diagnostic device industry, preferably in immunology, blood banking, clinical chemistry and hemostasis, and with both instrumentation and reagents.    Strong computer skills required.  Knowledgeable in Access, Word, Excel, Statistical software, e.g., Analyse-It  Excellent verbal and written communication skills – must have technical writing ability. Strong interpersonal skills with ability to interact with personnel at all levels. Must be capable of multi-tasking with the ability to work well with others in a TEAM environment. Job Location Los Angeles, CA, US. Position Type Full-Time/Regular