Regulatory Affairs Specialist - Medical Device

Proclinical is working with a Global Medical Devices company that is looking for Regulatory Affairs Specialist to support Life cycle management activities.

Job Responsibilities:

• Senior regulatory/clinical professional with specialized expertise in the regulation and clinical development of medical devices in European markets.
• Specific knowledge of the text and associated implications of the new European Medical Devices Regulation (MDR)
• Direct experience with driving medical device approvals (CE marking) in European markets, including specialized knowledge of design validation and verification procedures for medical devices.
• Prepare and attend meetings with Notified Bodies;
• Manage project, client expectations and satisfaction;
• Manage external subcontractors assigned to the project, such as medical writers and technical experts
• Working closely with the quality assurance and design teams you will have good knowledge of worldwide regulatory standards and demonstrable experience of ISO13485, CE marking, technical file submissions and of driving regulatory processes and activities.

Skills and Requirements:

• Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, PhD or other advanced degree (i.e. MBA) preferred.
• Fluent English both written and oral is essential
• Prior experience working for an Agency or Notified Body is a strong positive

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.