Mantell Associates is partnered with an innotive medical devices organisation, who are seaching for an MDR Project Manager to join the team. Reporting to the Regulatory Affairs Manager, your role is to manage the MDR project by coordinating and leading the project team according to the defined schedule.

MDR Project Manager - Responsibilities:

• Manage the progress of the project with department managers and management
• Develop and/or update project monitoring tools (dashboard, schedule monitoring, etc.)
• Ensure the quality of MDR submissions, within the set deadlines, and with the expectations of Notified Bodies and Competent Authorities for products containing a medicinal substance
• Provide regulatory support to teams impacted by MDR
• Participate in regulatory and normative monitoring of products manufactured and distributed in Europe and internationally
• Write and maintain regulatory technical files up to date, ensure coordination with the various departments involved and participate in marketing declarations
• Participate in the process of evaluating changes and their communication to the notified body
• Respond or participate in responses to regulatory requests from Authorities, Notified Bodies or customers
• Act as regulatory support/referent during the company's various projects
• Regulatory support for clinic questions
• Have a critical look at the documents submitted for registration/CE marking
• Define, propose and implement areas for improvement
• Take charge of assigned projects

MDR Project Manager - Requirements:

• Coming from a higher scientific education (Bac+5), you have a minimum experience of 5 years within a Regulatory Affairs department in the Medical Device (ideally DM class III) during which you have piloted less a working group and operated in project management
• You know how to unite around a subject; good communicator, constructive, you are proactive in solving problems and unblocking situations; you are recognized for your rigor, your capacity for analysis and synthesis
• Finally, your excellent interpersonal skills will allow you to take on this high-stakes challenge within the company
• Fluent in English & 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.