REGULATORY AFFAIRS SPECIALIST 3
1388 Kifer Road Sunnyvale, CA 94086
Our client manufactures and markets robotic products designed to improve clinical outcomes of patients.
Primary Function of Position:
Serve as the primary regulatory representative on Product Engineering and Manufacturing teams. Responsibilities include reviewing design input/output, performing regulatory assessments to determine the impact of design/process changes, maintaining regulatory filings and licenses and interacting with regulatory agencies during inspections.
Roles and Responsibilities:
- Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation.
- Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets.
- Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filling justifications, Technical File updates, Canadian License Applications
- Work with other international regulatory counterparts to coordinate global regulatory submissions/approvals
- Provide oversight of third-party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
- Perform other duties as required
- In-depth understanding of FDA, CE mark and Health Canada regulations
- Ability to work with cross function project teams and understand complex products
- Ability to work in a fast-paced environment and handle multiple projects simultaneously
- Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
- Ability to review and provide critical feedback on design documentation
- Able to learn internal procedures and processes and implement the same on project teams.
- Good interpersonal skills and project management skills.
- B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred.
- Non-technical degree with equivalent complex medical device experience acceptable
- 8 years relevant experience working in a medical device company
- 6 years of experience in regulatory submissions and technical documentation for a medical device company
- Experience working with cross-functions teams including engineering, manufacturing, regulatory, quality etc.