Mantell Associates is partnered with an innovative Medical Devices organisation, who are searching for a Regulatory Affairs Specialist to join their growing team. 

Regulatory Affairs Specialist – Responsibilities:

• Responsible for managing change control processes within the organization, including performing regulatory assessments and coordinating with project leaders
• Participate in weekly meetings with senior management to discuss regulatory updates and coordinate implementation of changes with the export team
• Analyze reports and collaborate with internal regulatory and standards experts to ensure compliance with regulations
• Review periodic reports provided by subcontractors and coordinate implementation of necessary actions with internal experts, reporting progress to management
• Serve as the Product Range Leader for 2 MDR (Medical Device Regulation) files, working closely with experts and maintaining MDD (Medical Device Directive) technical files
• Lead the regulatory aspects of cosmetics, including training on regulations and collaborating with the R&D cosmetics team to ensure product compliance
• Act as a backup for regulatory responsibilities in cosmetics and train to become proficient in this area
• Coordinate with cross-functional teams to ensure new product designs meet regulatory requirements and facilitate smooth change control processes

Regulatory Affairs Specialist – Requirements:

• Possess 2-4 years of regulatory affairs experience in the medical devices industry, focusing on Class IIB and III devices
• Preferred experience in cosmetics regulatory affairs
• Background in toxicology is advantageous but not required
• Familiarity with regulatory affairs in the EU and US, with a global perspective
• Fluent in English and French

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

Tagged as: Regulatory