Careers at AMT medical

Quality & Regulatory Manager (FT)

You probably know someone close to you who has undergone open-heart surgery and is experiencing the enormous impact of this. With us you help to bring a solution to the market so that it is no longer necessary to fully open the chest in the future with bypass surgery. As a result, many more heart patients can be helped. How beautiful is that?

AMT Medical has a small, passionate team of 15 professionals (young and old). We are based in Ede with the corporate office and production facilities (including a cleanroom). In Utrecht (Science Park) we have laboratories for bench testing.

Function description:

  • You support the Director Quality and Regulatory on all activities regarding the Quality Management System (QMS) and Regulatory Affairs.
  • Support the supervision of the required QA/RA processes and maintain quality and regulatory awareness at all relevant AMT functions.
  • Develop and maintain QMS compliance following ISO 13485:2016, 21CFR 820 (FDA), EU Medical Device Regulation and other applicable (product) standards and guidelines. Preferably also knowledge of other regulations (such as FDA).

 

Qualifications and educational requirements:

  • Relevant bachelor’s or master’s degree preferred in technical or life science related topic.
  • At least 3 years of experience in a QA/RA position in a medical device company.
  • Knowledge of or experience with ISO 13485, ISO 9001, 21 CFR 820, EU Medical Device Regulation (MDR) and preferably FDA experience, as well as relevant (product) standards/regulations.
  • Trained as QMS auditor.

 

Preferred Skills:

  • Highly proficient in spoken and written English, proficiency in other languages is a plus.
  • Ability to write quality and Technical File documentation at scientific level.
  • Effective interpersonal communication skills – both written and oral.
  • Accurate, detail oriented and able to see the big picture.
  • Result driven, willing to take that extra step.
  • Work independently and be self-motivated.

 

We offer:

  • An international work environment in a diverse team.
  • Salary according to education and experience.
  • 25 paid holidays (based on full time) and a pension plan.

 

If you recognize yourself in above profile, send your application and CV to joke.heemskerk@amt-medical.nl.
In case of questions, please contact us by Email.

Acquisition because of this advertisement is not appreciated.

Clinical Study Coordinator (FT)

You probably know someone close to you who has undergone open-heart surgery and is experiencing the enormous impact of this. With us you help to bring a solution to the market so that it is no longer necessary to fully open the chest in the future with bypass surgery. As a result, many more heart patients can be helped. As a clinical study coordinator, you will play a crucial role in conducting our clinical trials, collecting data for CE certification and FDA approval.  How beautiful is that?

AMT Medical has a small, passionate team of 15 professionals (young and old). We are based in Ede with the corporate office and production facilities (including a cleanroom). In Utrecht (Science Park) we have laboratories for bench testing.

Function description:

  • Supports, facilitates and coordinates the clinical trial activities.
  • Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
  • Instructs research staff in scientific and procedural aspects of the studies. Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

 

Qualifications and educational requirements:

  • At least 2 years of experience in a similar position in a medical device company.
  • Relevant bachelor’s or master’s degree preferred in medical/ scientific related topic.

 

Preferred Skills:

  • Excellent organizational skills.
  • Highly proficient in spoken and written English, proficiency in other languages like German is a plus.
  • Exceptional interpersonal communication skills – both written and oral.
  • Analytical, Accurate, detail oriented and able to see the big picture.
  • Result driven, willing to take that extra mile.
  • Ability to work independent and be self-motivated.
  • Willingness to continually self-educate.

 

We offer:

  • An international work environment in a diverse team.
  • Salary according to education and experience.
  • 25 paid holidays (based on full time) and a pension plan.

 

If you recognize yourself in above profile, send your application and CV to joke.heemskerk@amt-medical.nl.
In case of questions, please contact us by Email.

 
Acquisition because of this advertisement is not appreciated.