Regulatory Affairs Specialist - Medical Devices

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
Posting date: 27 Mar 2019

ProClinical is partnering with a leading contract research organisation (CRO) to advertise a vacancy for a Regulatory Affairs Specialist Medical Devices position. The company provides services across a range of areas, including medical device, in vitro diagnostics, pharmaceutical, clinical, and regulatory fields. Based with the company's Swiss-office, this position is an exciting opportunity to work with an acclaimed biotechnology company.

The ideal Regulatory Affairs Specialist will have a talented, independent and self-motivated regulatory mindset. The role offers the chance to join a team that will not only provide a wide variety of experience in regulatory projects but will also provide all the support needed to develop a regulatory career.

Job Responsibilities:

  • Establishing strong relationships with clients and regulatory agencies.
  • Working on a wide variety of medical device projects (Class I to III).
  • Providing regulatory expertise in the development, registration, and post approval activities of medical devices.
  • Ensuring high quality and timely consulting service delivery.
  • Managing a team of regulatory specialists.
  • Maintaining an up-to-date knowledge on the current EU Medical Device Directive and upcoming changes in the Regulation.
  • Developing experience and knowledge of medicines and drug-device combination products.

Skills and Requirements:

  • A graduate degree from a Life Sciences or Pharmaceutical field, ideally with a post-graduate qualification.
  • Medical experience in the regulations of Class II/III medical devices.
  • At least 5-7 years of experience in the medical devices field of regulatory affairs.
  • Sound knowledge of the medical device Directive/Regulation.
  • Solid regulatory affairs experience, including a successful track record in writing medical device technical files.
  • Experience in project management and food supplements is desirable.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Stefania Bernardi at +44 203 078 9543 or upload your CV on our website -

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.