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