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Medical Device Regulatory Affairs Manager

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Altran is a global engineering consultancy and leader in R&D Services (ER&D), offering its clients a new way to innovate by developing products and services of tomorrow. Being a consultant for Altran means working alongside our clients on every link in the value chain of their project, from concept stage to industrialization. The Altran Group provides its expertise to key players in the Life Sciences sectors for Medical Devices-, Implants-, Laboratory Equipment Systems-, Biotech & Pharmaceuticals-, and Medical Device Apps.

Currently we are looking for a

 

Medical Device Regulatory Affairs Manager

 

Responsibilities

  • Develop, implement, communicate, and maintain global regulatory strategies and plans for devices
  • Identify and communicate relevant guidance, policies, standards, and regulations
  • 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
  • Perform change management assessments; determine and communicate post-approval reporting requirements
     

Your Profile  

  • Masters degree in Regulatory Affairs, Life Sciences, or Engineering
  • Minimum 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        

      

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.

We are looking forward to receiving your application! We only accept applications through our online career portal. Applications via e-mail or 3rd party platforms will be deleted due to GDPR regulation. Your application may be considered for other open positions.

Adresse

Altran AG
Ms Aude Goepfert
Recruiter
Aeschenvorstadt 71
4051 Basel

Website http://www.altran.ch

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