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Regulatory Affairs Specialist

Location: Fremont, California
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The Regulatory Affairs Specialist is responsible for establishing strategy for worldwide product approval submission activities, directly responsible for submission activities and for ensuring regulatory compliance. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs. Collaborate with International RA, R&D, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.

Key Responsibilities: 

  • Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration.
  • Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
  • Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
  • Drive product change assessments and define regulatory impact of product changes in global markets.
  • Review and approve labeling, training, promotional, and advertising material.
    Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.
  • Ensure compliance with Thermo Fisher Scientific, U.S. FDA, EU MDR/IVDR, Korea MFDS, China NMPA and other international medical requirements.
  • Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA, HHE, issue assessments).
  • Facilitate and prepare U.S. regulatory Pre Submission documents and pre submission meetings
  • Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.
  • Prepares documents vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, PM, De Novo, and technical files for CE marking.
  • Support global regulatory registration representatives for product global registration activities
  • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
  • Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
  • Assist Regulatory department in the update, improvement, and creation of internal policies and procedures.
  • Participate in business meetings with external partners as needed.
  • Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.

Minimum Requirements/Qualifications:

  • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related
  • science.
  • Must have a minimum of 5 years of IVD Regulatory Affairs experience.
  • This experience must include either 510(k), De Novo, PMA, PMA supplement submissions.
  • Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
  • Excellent knowledge of U.S. and European/International regulations and standards.
  • RAPS’ Regulatory Affairs Certification (RAC).
  • Experience interacting with FDA and/or other regulatory agencies.
  • Experience reviewing design specifications and other technical documents.
  • Previous experience in EU MDD/IVDD or MDR/IVDR.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

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