A global healthcare leader is seeking to hire a Regulatory Affairs Manager to join their growing team in Donegal Town. As a Regulatory Affairs Manager, you will apply advanced regulatory expertise to guide cross-functional teams and strategically support key business programs. Collaborating with Regulatory leadership, you will develop and implement regulatory strategies, ensuring efficient product introductions and postmarket change management activities across global markets.
Responsibilities: (Full job description available on request):
- Develop and implement regulatory strategies for product introductions and modifications in alignment with schedules.
- Maintain comprehensive documentation of regulatory decisions and validation evidence for change control activities related to product design or manufacture.
- Provide strategic regulatory input, ensuring cross-functional alignment regarding issues with potential regulatory impact.
- Oversee the effectiveness of the Quality System, ensuring compliance with divisional, corporate, and regulatory requirements.
- Manage the preparation of registration documents for international markets.
- Offer input and commentary on regulations and standards that may impact division products.
- Bachelor's Degree in a relevant field or equivalent combination of education and work experience.
- Minimum 6 years of medical device regulatory experience, including submissions for new products and product changes in the medical device industry.
- Extensive experience with US and EU medical device submissions and regulations.
- Ability to excel in a highly matrixed and geographically diverse business environment.
For a confidential discussion and more information on the role, please contact Courtney Russell
+353 71 9108062