Job Description
This well-established consumer goods company, operating in the US, UK and Europe, seeks a Head of Regulatory to serve as their EU point of contact and lead a team of regulatory professionals across EU/UK.
Responsibilities:
* Serve as a liaison between UK/EU management and Quality, QA Manufacturing, and Regulatory departments.
* Oversee 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 impact of regulatory changes to the business and global partners.
Requirements:
* Mandatory: In-depth knowledge of European Medical Devices legislation.
* Beneficial: Experience with cosmetics, Pharmaceuticals, Electrical products, Food supplements, or detergents.
* Familiarity with MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).
* Desirable: French language proficiency.
* Essential: Experience liaising with regulatory bodies and ability to work cross-functionally.
Estimated salary: £80,000 - £100,000 per annum.