Regulatory Affairs Specialist – Donegal
The Regulatory Affairs Specialist partners across business functions, contract manufacturers, Third Party Manufacturers (TPM) and strategic/Tier-2 suppliers in support of key business programs. The individual may assist in identifying data needed, reviewing and approving documentation containing these data and ensuring that they are effectively presented for the registration of products or post-market change management activities into global markets. Review and approve company and Third Party Manufacturing validations, and Supplier Change Notifications for implementation at site, TPM and Tier-2 Suppliers as applicable. Exercise judgment within generally defined practices and departmental Standard Operating Procedures (SOP). Develop and maintain strong and effective relations with internal/external personnel, including project stakeholders.
Major Responsibilities:
- Works with Regulatory leadership to 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.
- 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.
- Prepares, or provides 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.
Education and Years Experience:
- Relevant third level degree in a relevant scientific or related discipline (e.g. life sciences or healthcare such as medicine, pharmacy, biochemistry, engineering, biotechnology)
- Minimum 2 years’ experience in Engineering / Manufacturing / Science preferred
- Knowledge of relevant European and National legislation for medical devices
- Excellent communication skills with the proven ability to deliver appropriate information to the right people, using a range of written, verbal and presentation skills
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For a confidential discussion and more information on the role, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie
071 9140251