Qualifications and Skills Required for Success in This Role:
- A BS/MS in life sciences coupled with at least 3 years of experience in regulatory affairs.
- Preferred certification in regulatory affairs.
- Extensive knowledge of both US and international regulations.
- Exceptional written and verbal communication abilities.
- Keen attention to detail.
- Proficiency in technical systems (e.g., MS Office, SharePoint, statistical software, online research).
- Capability to handle multiple projects and meet deadlines.
- Strong grasp of statistical analysis.
- Skill in identifying compliance risks and escalating issues as needed.
- Required experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA)
Job Responsibilities:
- Represent or lead Regulatory Affairs within project teams throughout the product lifecycle.
- Draft and review protocols for analytical studies supporting regulatory submissions.
- Assist in the preparation and submission of EUAs, pre-submissions, and 510(k)s.
- Support international registrations, develop and maintain technical files, and prepare product dossiers.
- Prepare and maintain Design History Files.
- Lead Risk Management efforts.
- Prepare and review labeling and marketing materials to ensure regulatory compliance.
- Contribute to setting regulatory strategies for new product development.
- Stay updated on the latest regulatory requirements and trends.
- Communicate with the FDA and other regulatory agencies regarding product submissions.
