Regulatory Affairs Manager
21 hours ago
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OnsiteFull-timeMid
Summary
Connecticut Innovations is seeking a Regulatory Affairs Manager to join their team at Perosphere Technologies in Danbury, CT. The role involves coordinating global regulatory registrations and managing US regulatory submissions for a diagnostic medical device.
About the Role
As a Regulatory Affairs Manager, you will be responsible for planning registration strategies for new products, preparing FDA pre-market 510(k) filings, and providing compliance advice regarding FDA and OUS regulatory requirements. You will work closely with marketing, technical, and clinical teams to ensure successful product registrations and submissions.
About You
Required:
- Bachelor of Science in Chemistry, Biology, Medical Technology, or related area from an accredited four-year college or university.
- Minimum of 3 to 5 years experience working in a regulatory submissions or compliance capacity in a regulated medical industry, preferably the Medical Devices industry.
- Experience with US FDA filings and updates related to premarket approval, e.g., 510(k).
Preferred:
- Advanced degree MS in a relevant field.
- Knowledge of program management tools such as MS Excel and MS Project.
- Ability to mentor others regarding regulatory requirements.
Benefits
- Purpose-driven work that helps shape the standard of care for millions of patients.
- Opportunity to work in a market with ~$1B addressable market across U.S. and EU hospital systems.
- Be at the forefront of hospital-based precision diagnostics.
Connecticut Innovations
CI is Connecticut’s strategic venture capital arm and is the leading source of financing and ongoing support for innovative, growing companies. By offering equity and debt investments, strategic guidance and introductions to valuable partners, we help promising businesses to thrive. Learn more at ctinnovations.com
New York City Metropolitan Area