Head of Regulatory Affairs
2 months ago
This company is a household name and is a well-established consumer goods company, based out of the US/UK/Europe. They are searching for a Head of Regulatory to act as their EU point of contact and lead a team of regulatory professionals across EU/UK.
Responsibilities:
- Act as a liaison between UK/EU management and the Quality, QA Manufacturing, and Regulatory departments.
- Oversee the development and management of regulatory documents, including technical files and dossiers.
- Provide strategic guidance on EU regulatory compliance for medical devices and pharmaceuticals.
- Manage project assignments related to investigational, new, and marketed products.
- Support third-party and competent authority audits.
- Gather regulatory intelligence from government agencies and trade associations.
- Communicate the impact of regulatory changes to the business and global partners.
Requirements:
- In-depth knowledge of legislation for Medical Devices across Europe is mandatory
- Experience with cosmetics, Pharmaceuticals, Electrical products, Food supplements, or detergents would be beneficial
- Familiarity with MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001)
- Experience with French language would be a plus
- Experience liaising with regulatory bodies and able to work cross-functionally
Please apply now to be considered for the initial shortlist.
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Head of Regulatory Affairs
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