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Medical Device Regulatory Expert

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €140,000
Regulatory Affairs Manager Job Description

We are seeking a highly motivated and experienced Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.

The successful candidate will be responsible for leading the regulatory strategy for new product introductions and supporting existing products through their full lifecycle. They will manage regulatory submissions (e.g., 510(k), CE Mark) and global product registrations, act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe, monitor and interpret evolving regulatory requirements, and apply them to ensure company compliance.