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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist
Do you want to be a Senior Regulatory Affairs Specialist? I am currently looking for a Senior RA specialist on behalf of a growing, international organisation in the medical devices industry. You will be part of the Regulatory Affairs department, together with five RA professionals. As a Regulatory Affairs Specialist you will report to the Regulatory Affairs Manager on site. This professional medical devices organisation is located in Limburg.

You will be responsible for:

  • Ensuring that the assigned products are in compliance with the relevant regulations;
  • The coordination, preparation and maintenance of submissions for the EMEA region and Europe;
  • Defining regulatory requirements for EU and EMEA submissions;
  • The coordination of recalls;
  • Participating in complaint handling by analysing complaints and making recommendations;
  • Assisting with audits from notified bodies and FDA facility inspections;
  • The coordination of internal audits in collaboration with the audit department;

You will need to have the following skills

  • At least a bachelor degree relating to the following sciences: physical, biological, material or engineering;
  • At least six years of experience in the medical devices
  • You have a good understanding of the international regulatory environment and the specific regulations in the EMEA region;
  • Knowledge of ISO 13485, the MDD and FDA terminology;
  • As English is the main language, your level of English needs to be sufficient (verbal and written);
  • Good communication skills;
  • You work accurately;

The offer

  • Year contract with the possibility to obtain an indefinite contract after one year
  • A competitive salary (+/- €65.000 euro gross based on knowledge and experience) excluding 8% holiday allowance
  • Travel allowance;
  • Laptop;
  • 26 holidays.

Interested in this role?
Are you the Senior Regulatory Affairs Specialist I am looking for? Please don't hesitate to contact Joey Wielkens on the phone number 020-5221577 or send an e-mail to j.wielkens @ realstaffing.com. You may also contact me if you have questions about this role.