EU MDR/IVDR Regulatory Lead for MedTech & Diagnostics

Johnson & Johnson Innovative Medicine

Allschwil

Hybrid

CHF 110.000 - 150.000

Vollzeit

Vor 7 Tagen

Sei unter den ersten Bewerbenden

Bewerbungsgenerator

Eine vollständige Bewerbung in einer Minute — Lebenslauf und Anschreiben, maßgeschneidert und versandbereit.

Schaffe es an den ATS-Filtern vorbei

Benefits dieser Stelle

Annual bonus

Vacation days

Zusammenfassung

Johnson & Johnson Innovative Medicine seeks a Manager, EU Medical Devices & IVD Regulation to lead regulatory strategy and QMS integration for our global clinical development programs. You will act as the subject matter expert on EU MDR/IVDR, guiding cross-functional teams across Regulatory Affairs, Quality, Clinical Development and Data Science in Beerse, Switzerland, or related sites.

The role requires a Bachelor’s degree in Life Sciences or related field and at least 5 years in pharma/biotech

Qualifikationen

Experience with EU MDR/IVDR and FDA medical device regulations.
Ability to translate regulatory requirements into QMS controls, procedures and training.
Strong cross-functional partnering with Regulatory, Quality, Legal and Clinical teams.

Aufgaben

Monitor and interpret new EU MDR/IVDR regulations and assess impact on Clinical Development and QMS.
Lead regulatory impact assessments, gap analyses, risk evaluations and implementation plans.
Support audits, inspections, CAPAs and continuous improvement initiatives while driving governance documents.

Kenntnisse

EU MDR/IVDR regulations

Regulatory compliance

Cross-functional collaboration

Quality management systems

Risk assessment

Ausbildung

Bachelor's degree in Life Sciences / Pharmacy / Engineering / Quality Management

Jobbeschreibung