Senior Regulatory Affairs Specialist
Job Summary
Providing regulatory affairs support for digital health and software products, the full-time Senior Regulatory Affairs Specialist will prepare regulatory submissions, assist with compliance activities, and collaborate with cross-functional teams in an on-site role based in Madison, New Jersey.
Key responsibilities
- Prepare and submit regulatory documents such as IDEs and PMAs to the FDA and Health Canada
- Support pre-market and post-market regulatory activities for assigned projects
- Collaborate with cross-functional teams to ensure compliance with regulatory standards and requirements
Required qualifications
- Bachelor's degree in engineering, life sciences, or related fields
- 3-8 years of regulatory experience with Class II/III medical devices and software products
- Working knowledge of FDA processes and GMP compliance requirements
- Experience with Software as a Medical Device (SaMD) and cybersecurity
- Ability to travel 5% of the time domestically or internationally
Complete Job Description
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