Contact us. We may have an opening for a medical device consultant.
- Consult with medical device manufacturers, and assist them with the implementation of the European Medical Device Regulations;
- Gather, create, and review technical documentation;
- Implement ISO 13485 Quality Management Systems;
- Conduct internal audits at the costumer’s site;
- Stay up-to-date on changes to the European Medical Device Regulations and related standards.
- Minimum of 5 years’ experience in the medical device industry, health care or related services;
- Experience with Quality Management Systems for medical devices;
- Minimum education: Bachelor’s degree in (life science) technology or biochemistry;
- Proficiency in English and Dutch language.
- Experience as a quality / regulatory affairs manager in the medical device industry or a similar level in a healthcare facility, a regulatory body or a healthcare authority;
- Experience as (lead) auditor for Medical Device Regulations or quality management standards;
- Experience with international enterprises;
- Willingness to travel;
- Preferably located in Utrecht (NL) area.
- Substantial worldwide client base;
- Interaction with our international team members, regulatory bodies, and EU Authorities;
- An informal but professional work environment.
To apply, please submit your resume and cover letter to email@example.com