Contact us. We may have an opening for a medical device consultant.

 

Responsibilities

• 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.

Requirements

• 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.

Desired

• 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.

We offer

• 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 jobs@cepartner4u.nl

 

(Acquisitie naar aanleiding van deze vacature wordt niet op prijs gesteld.)