The Client
My client is a large pharmaceutical manufacturer, with 3200 people employed across 11 sites, 6 of which are based in Ireland.
We are currently recruiting for a Regulatory Affairs Manager to be based in Co Donegal.
The Role
· Works with Regulatory leadership to develop and implement regulatory strategies for product introductions and modifications per agreed schedule.
· Maintains strong communication and working relationships with all departments across division sites, Third Party Manufacturers, suppliers, and external personnel.
· Ensures that appropriate documentation is maintained to record regulatory decisions and verification/validation evidence in support of change control activities related to product design or manufacture.
· Maintain a high level of technical understanding with all new products.
· Provides strategic regulatory input (including all feasible alternatives and associated risks) and drives cross-functional alignment with issues that could have regulatory ramifications.
· Maintains the effectiveness of the Quality System at the site in accordance with divisional and corporate requirements and applicable regulations.
· Manages the preparation of registration documents as required for international markets. Provides input and comment on regulations and standards which may affect division products. Accountable for cross-functional project communication.
The Person
· Third Level Qualification in Quality Science or Engineering.
· Minimum 6 years Medical device regulatory experience, including submissions for new products and product changes in the medical device industry
· Extensive US and EU medical device submissions and regulations
Next Steps
To discuss this role, or other roles in life sciences, call Seamus on 02890725625. Or send your CV using the link provided.
