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Regulatory Affairs Director

1 week 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 lead its Regulatory Affairs Sub-Function. The successful candidate will be responsible for managing teams and overseeing 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 attention to detail and solid communication skills, with the ability to communicate at all levels. Experience with EU and US regulatory bodies, as well as people management experience, are essential for this role.

Responsibilities include interacting with regulatory agencies to expedite approval of pending registration, serving as regulatory liaison throughout the product lifecycle, and participating in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).

In order to succeed in this position, 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.