Director of Regulatory Affairs
Personal Genome Diagnostics (PGDx) is seeking a Director of Regulatory Affairs to help in the fight against cancer by leading the regulatory submission teams to enable global access to our IVD products. Qualified candidates will have extensive knowledge of domestic and international regulatory requirements.
- Lead the submission of documents to FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies.
- Direct the submission of documents to CFDA, PMDA, and other Asian markets.
- Proactively partner with R&D, Marketing, and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets.
- Develop and approve appropriate technical documents for regulatory planning in support of project development
- Develop and maintain Technical Files for CE marking.
- Assess the regulatory impact of post-market changes to labeling, design, materials, or manufacturing process.
- Represent regulatory affairs on product development teams.
- Identify and implement process improvements for regulatory affairs
- Review new regulations for implications for the company and recommend a strategy to achieve compliance with requirements.
REQUIRED EDUCATION AND EXPERIENCE:
- Required 6-8years in regulatory affairs within the medical device industry (IVD experience highly preferred).
- Experience in ex-US regulatory submissions required.
- Minimum Bachelor’s degree in a technical discipline required; Master’s Degree in a technical discipline preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Must be able to work independently and efficiently to complete multiple projects within deadline.