Regulatory Affairs Lead — FDA Submissions & Global Compliance

A clinical research organization located in Connecticut seeks a Regulatory Affairs Specialist to guide regulatory submissions and lead project teams. Candidates should have a B.Sc. in a related field and at least 4 years of IVD Regulatory Affairs experience, particularly with 510(k) and PMA submissions. Strong communication and project management skills are essential. This role supports global registration activities and facilitates FDA pre-submission meetings.
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