Medical Devices

Senior Regulatory Compliance Specialist

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About the job

Do you have a Bachelor’s Degree in a Scientific or Engineering field as well as a minimum of 3 years experience in compliance and/or quality system activities in a QSR/ ISO 13485 Quality Management System and MDSAP audit? Are you looking to join a global leader in medical devices?

Invenia Group has partnered with a global leader in medical devices that is currently seeking a Senior Regulatory Compliance Specialist to become the newest member of the Regulatory Affairs/Quality Assurance team located in the company’s Amsterdam office.

Role responsibilities: 

If successful, you will be responsible for integrating the Global Quality Management System processes to maintain certification for the facilities in the designated region. You will also support the maintenance of CE marking of the company’s product portfolio through registrations and interaction with Competent Authorities or Notified Bodies. 

What we are looking for: 

We are looking for an individual with a Bachelor’s Degree in a Scientific or Engineering field required, as well as a minimum of 3 years experience in compliance and/or quality system activities in a QSR/ ISO 13485 Quality Management System and MDSAP audit. You should also possess the following: 

  • Knowledge of regulatory requirements GMPs, MDD / MDR
  • Knowledge of RoHS Directive, GDPR, and REACh regulation
  • A demonstrated knowledge, understanding, or application of audit principles, concepts, and practices related to a regulated quality system
  • The ability to complete regulatory reports and provide timely, written correspondence to internal and external customers including regulatory bodies

This is a fantastic opportunity to join a growing organisation and equal opportunity employer that strongly supports diversity in the workplace. This role can be remote-based but must be willing to travel to the office 1-2 days per week. To find out more information regarding this role, please apply.