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European Regulatory Affairs Director
1 month ago
A dynamic and experienced European Regulatory Affairs professional is sought to lead our team in ensuring compliance and driving strategic initiatives across Europe. The ideal candidate will have a knack for navigating complex regulatory landscapes and a passion for ensuring compliance.
Key Responsibilities:- Direct the development and management of regulatory documents, including technical files and dossiers.
- Provide guidance on EU regulatory strategy and compliance for medical device and pharmaceutical products.
- Act as a liaison with government agencies and trade associations to gather and anticipate regulatory changes.
Strong leadership skills with a focus on results and business are essential. The ability to exercise sound judgment, manage multiple projects, and work cross-functionally is also required. Fluency in a second language (ideally French) is preferable.
Previous experience in Medical Device is essential; experience in additional sectors such as cosmetic and/or pharmaceutical drugs is beneficial. Knowledge of regulations such as MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001) is also required.
For more information on our company and our culture, visit us at http://www.churchdwight.co.uk/.