Product Registration Specialist

1 day ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl Healthcare is a multinational medical device and health care company seeking a Regulatory Affairs Manager to manage its Regulatory Affairs Sub-Function. The successful candidate will oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

The ideal candidate will have strong leadership skills and experience working with regulatory agencies. They will be responsible for interacting with regulatory agencies to expedite approval of pending registration and serving as regulatory liaison throughout the product lifecycle.

Responsibilities include participating in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC). To succeed in this role, candidates must have minimum 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience. A Level 8 Degree in Engineering or Science or related discipline is also required.



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