Medical Device Specialist (Regulatory Affairs)

Switzerland  ‐ Onsite
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Description

Medical Device Specialist (Regulatory Affairs)

Location: Central Switzerland

Duration: to

Responsibilities:
  • Know and apply guidelines provided by the company code of conduct (company) and by relevant national laws
  • Make sure that the medical devices are compliant with the product development process and with the applicable regulatory requirements (MDD 93/42/EEC)
  • Organisation and administration of technical documentation
  • Update the technical documentation regarding current and new regulatory requirements and make sure that the documentation is conform with the EU and country specific requirements
  • Evaluation of medical devices regarding their risk potential (based on EN ISO 14971)
  • Establish and support product related information (IFUs, Surgical Technique guides)
  • Support international releases of medical devices
  • Prepare and support audits
  • Support optimisation of company internal procedures


Requirements:

Scientific, medical or engineering background

Minimum 1-3 years' experience in Regulatory Affairs (MDD 93/42/EEC) of Medical Devices

Experience in US Regulatory Affairs preferable

Language:

English (must)

German preferred

Personal Skills:
  • Able to work under pressure
  • Decisive
  • Communicative competence
  • Team player
  • Ability to assert oneself
  • Pragmatic and solution-driven working style


If this position sounds interesting to you, please feel free to contact me.

Sabina

Start date
06/2016
Duration
6 months
From
Real Staffing
Published at
02.06.2016
Project ID:
1140682
Contract type
Freelance
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