Job Detail

• Job TitleSenior Regulatory Affairs Specialist - Medical Devices


• Vacancy Reference Number19911


• Work SiteSwitzerland / | CHE - All Regions /
  - Basel
  - Bern


• Contract TypePermanent [Full-Time]


• Minimum number of years of experience required5 years of experience and more

Our offer

• A permanent contract with the leader in innovation and high-tech engineering consulting


• A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).


• In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.

Your role

• Ensure that the company's products comply with the regulations set up by government agencies


• Advise engineering and manufacturing on regulatory requirements


• Assist the review of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required


• Creation, review and maintenance of regulatory related technical documentation


• Work with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials


• Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals


• Provide progress of work-plans and the status of key project deliverables

Your profile

• Bachelor's (minimum 3 years’ experience) or Master’s (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.


• 3-5 years of experience in European Medical device industry especially with regulatory, quality or engineering 


• Strong knowledge of ISO 13485 and ISO 9001, QSR  and Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation


• Strong understanding of Risk Management process, label and labeling, change management is desired