Clinical / Regulatory Affairs:

Regulatory Affairs Manager- San Francisco

I am seeking an experienced Regulatory Affairs Manager in San Francisco which require significant 510(k) experience and at least 5 or more years working in a FDA compliance environment with ISO 14971, ISO 13485, and/or CAPA process. The position has a salary range from 100-125k with up to a 15% bonus. No relocation is available so either local candidates or those willing to relocate on their own are encouraged to apply.

This role will execute regulatory strategy and plans for earliest possible approvals to meet product development and release schedules. Perform the coordination and preparation of product registration files for submissions in the US, Canada, EU and select worldwide locations. Perform regulatory determinations and generates Letter-to-Files for product modifications & assessments. You'll be tasked with representing or leading the RA function and compliance representative on assigned cross-functional project teams.

  • Keep abreast of standards and regulations. Identify, interpret and provide guidance on applicable safety, performance standards (e.g. IEC & Harmonized Standards) for the development, testing and evaluating the accuracy and reliability of my client's products and QMS. Key contributor to the maintenance of external list of standards and regulations.
  • Participate / assist in internal audits. May also direct interaction with regulatory agencies on defined matters and site inspections.
  • Performing the generation, review and documentation of the assessments and mitigations resulting from the risk management process as well as privacy and security risk assessments.
  • Coordinating all aspects of US and International regulatory filings, including the completion of all compliance related testing (EMC, Safety, Shock & Vibration) to assure that the product designs conform to all applicable regulatory agency codes and standards, both domestic and international;
  • These positions require a high degree of technical comprehension of medical device regulatory requirements: FDA regulations, MDD and medical device safety standards and regulatory compliance guidelines. Strong experience with the development of device/system risk plan and analyses using processes defined in ISO 14971 and IEC standards/guidelines for medical devices and software (such as IEC 62304).

    • Technical & Experience Requirements:

    • Position require a minimum of a Four-year degree or equivalent combination of education and experience. Regulatory Affairs Certification is also desirable.
    • Requires 3 years experience in the interpretation and application of US/International medical device regulations
    • Extensive experience with 510k,CAPA and complaint handling. Actually having authored and signed off on 510k submissions is a deciding plus!
    • Excellent technical writing and verbal communication skills plus outstanding listening skills to interact with clinical staff, FDA, and internal staff and to develop programs.
    • Strong experience with the development of device/system risk plan and analyses using processes defined in ISO 14971 and IEC standards/guidelines for medical devices and software (such as IEC 62304).

    Please apply with your resume to resumes@hireforyou.com

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