Senior Associate Regulatory Affairs (Medical Devices)

Description Overview

We are excited to be recruiting for an Senior Associate in Regulatory Affairs to be based in either Ghent, Rotterdam, London or Paris. Paris, France or Ghent working on our exciting Medical Device Portfolio. 

The main responsibilities of the role will be to work on a diverse range of Regulatory Affairs projects to meet business needs and ensure Regulatory Compliance of the company’s products with all relevant legislation around Medical Devices, including the MDD, the challenging new MDR, ISO 13485, ISO 14971 and other harmonized standards.

Scope of the Role

• Work as part of a multi-functional team (Quality, Innovation, Marketing, Supply, etc..) by providing regulatory input to changes happening to the products, including artwork approvals, label claims and associated supporting documentation within assigned categories
• Depending on experience, represent the regulatory department in projects as primary point of contact, including new product developments and provide input to management
• Interpret and implement changes in legislation following Regulatory Intelligence;  proactively manage impact of these changes
• Discuss strategy and issues internally and with authorities/third parties as needed
• As part of the team ensure product registrations where Perrigo are both Legal Manufacturer or Distributor are correct and compliant with the relevant legislation
• Provide the Quality team support in maintaining the ISO 13485 Quality Management System
• Assist in the process of reporting and investigating critical non-conformities, corrective / preventive actions and look for opportunities for improvement
• Provide input to risk management plans and risk management files in line with ISO 14971
• Maintain, review, approve and update of technical files compliance with the MDD 93/42/EEC and MDR EC/2017/745
• Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory

Experience Required