Senior Regulatory Affairs Consultant, Medical Devices - EU locations

We are recruiting for a Senior Consultant, Regulatory Affairs to lead our regulatory activities for Medical Device projects (EU MDR)

The role can be flexibly based in several EU locations based on candidates' skills and experience.

Scope of responsibilities: Regulatory Leader activities for medical device projects including: regulatory submissions for all phases, multinational clinical studies for European and Non-EU countries (e.i. Asia-Pacific, Latin America). Single point of contact for RA submission strategy and consulting. Liaison with local regulatory teams, PXL global team and the Sponsor. Global regulatory intelligence. Labelling consultation. QualificationsIdeal candidate will possess: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred. Extensive years of experience in a CRO or industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus. Experience with In Vitro Diagnostic (IVD). Experience with Clinical Investigations. Experience with Post Marketing Clinical Follow up studies. Previous experience with the former EU Medical device directive would be an asset. Knowledge about Gene, cell therapy, biosimilars and non-interventional trials would be an asset. Fluency in English language. Critical thinking and problem-solving skills. Project leadership and management knowledge. Excellent interpersonal and intercultural communication skills, both written and verbal. Client-focused approach to work.