Job Information
Philips Regulatory Affairs Specialist, European Authorized Representative (EU AR) Officer in Best, Netherlands
Your role:
Verify EU declaration of conformity and technical documentation is drawn up and kept up to date and, where applicable, that an appropriate conformity assessment procedure has been carried out
Approve product release for acquisition and delivery for Europe (including significant product change)
Keep available a copy of the technical documentation, the EU declaration of conformity and, of the relevant certificates to the National Competent Authorities
Comply with the EU registration obligations
Cooperate with the competent authorities, providing them with the requested information related to device conformity, vigilance and preventive & corrective actions
Forward to the manufacturer any request by a competent authority, contribute and monitor the answer
Immediately inform the manufacturer about complaints and reports about suspected incidents he/she is made aware about
Escalate all unsolved device non-conformities, regulation violations and Competent Authority requests and inquiries to RA Director EU MDR Regulatory Compliance
Certificate of Free Sales
QMS procedures and Work Instructions follow-up and update
EU AR administrative tasks
You're the right fit if:
Bachelor degree in biological sciences, engineering or equivalent
Relevant experience in Regulatory Affairs activities in medical devices companies
A thorough understanding ISO 13485 and ISO 14971
Familiarity with the EU Medical Device Directive MDD (IVD appreciated) and Medical Device Regulation MDR (IVDR appreciated)
Experience in interacting with Notified Bodies and Competent Authorities
Ability to communicate effectively with QA/RA, R&D, Clinical Science and Marketing teams
Good communication skills, written and verbal
Proficiency in Microsoft Office applications
Regulatory Affairs Certification (preferred)
Fluency in English and in Dutch (preferred)
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
#LI-EU