Regulatory Affairs Specialist

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
Lugano
Posting date: 26 Feb 2019
RA.VC.20229_1551190729

ProClinical is advertising a vacancy for a Regulatory Affairs Specialist - Medical Devices with an internationally successful contract research organisation. This CRO, which has supported biotechnology, medical device, and pharmaceutical companies since 2015, is seeking an experienced and talented individual to join their team in Switzerland.

Job Responsibilities:

  • Working on a wide variety of medical device projects, from Class I to Class III.
  • Establishing strong relationships with clients and regulatory agencies.
  • Providing regulatory expertise to the development, registration, and post-approval activities of medical devices.
  • Ensuring high quality and timely delivery of consulting services to clients.
  • Managing a team of regulatory specialists.
  • Overseeing professional growth within the company.

Skills and Requirements:

  • A degree in a Life Science or Pharmacy field, ideally with a post-graduate qualification.
  • Medical experience in the regulations of class II medical devices.
  • Sound knowledge of medical device directives/regulations.
  • Thorough regulatory affairs experience, including a successful track record in writing medical device technical files.
  • Demonstrable experience in project management and food supplements a desirable attribute.
  • Capable of adapting to a small team.
  • An ability to learn, assimilate, and effectively communicate information to support colleagues, discuss with partners, and advise clients on requirements.
  • Strong interpersonal skills, including communication, leadership, relationship management, and influencing.
  • Capable of leading interdisciplinary projects and to implement change within a high-performing organisation.
  • Demonstrable computer software skills, including MS Office.
  • Fluency in English and Italian.

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 Keri Marshall on +44 203 854 0674 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.

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