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Principal Regulatory Affairs Specialist / Manager

  • Location


  • Salary

    US$140000.00 - US$160000.00 per year

  • Sector


  • Job Ref


  • Contact

    Dustin Graham

  • Published

    etwa 19 Stunden her

Expired job

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Manager / Principal / Senior Regulatory Affairs Specialist Location: San Jose, CA. Job Type: Full Time, on-site. But may consider a Hybrid mode for well-qualified candidates.

JOB DETAILS Must-have/Qualifications:

  • Bachelor's Degree or related technical or scientific discipline. Master's degree in Regulatory preferred or RAPS certification.
  • 5-10 years' experience in regulatory affairs within the medical device industry
  • Strong experience in EU Regulations (Medical Device directives (93/42/EC) and EU MDRs) required
  • Experience in FDA product submissions (IDE, PMA, 510k) required
  • Experience in writing/maintaining CE Technical Files preferred
  • Experience with ISO 13485:2016 and ISO 14971 required.
  • Excellent problem solving, decision-making, and root cause analysis skills are required.


  • Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
  • Provide guidance and approval regarding regulatory strategies and approaches.
  • Develop, Maintain and update regulatory documents such as technical files for CE
    marking, device master records, GSPR checklist, risk analysis, and design history files.
  • Participate and Support new product development teams to provide regulatory support to
    the project.
  • Represent regulatory affairs on engineering and R&D product development project teams
    to ensure all regulatory requirements are met through the development process and defining the requirements for regulatory submissions of products on international and domestic markets.
  • Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging and notifying regulatory agencies and NB of substantial changes.
  • Support post market activities and reportability to regulatory agencies.
  • Required to support communication with FDA and the Notified Body, preparing responses
    to questions or deficiency letters from regulatory agencies.
  • Support and implement transition plans to new MDR regulations
  • Required to maintain MDR system and compliance once implemented
  • Participate and represent regulatory affairs during FDA and NB site audits.