Job Description
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.