Regulatory Affairs Specialist

Location
Bonaduz
Salary
Competitive
Posted
01 Feb 2021
Closes
26 Feb 2021
Ref
49761
Contact
Jocelyn Blackham
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Jocelyn Blackham is recruiting for a Regulatory Affairs Specialist to join a Medical Device company at their site based in Bonaduz on a permanent basis.

The main purpose of the role will be to:
- Monitor and analyze changes in standards, laws and guidelines in ventilation technology, identifying the effects and determining an implementation strategy.
- Ensure the maintenance of the technical documentation.
- Check the completeness and correctness of project documentation.
- Assist in the preparation of of international registration dossiers

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Studies in the natural sciences, technical or medical fields or completed professional training plus practical experience and additional professional training (e.g. master craftsman, technician, specialist diploma)
- Knowledge of the IEC 60601 series is an advantage
- Knowledge of IEC 62304, FDA software / cybersecurity guidance documents is beneficial
- Experience in international approvals in the field of medical devices, especially 510 (k) and Health Canada is an advantage
- Fluent English and German knowledge is essential

This is an excellent opportunity to join a global medical device company.

Please could you send any correspondence in English. Please quote reference 49761 in all correspondence.

Similar jobs

Similar jobs