Regulatory Compliance Specialist (m/f/d)

As a first-tier supplier to our renowned business partner, Roche Diagnostics in Rotkreuz, we are immediately seeking a motivated and committed Regulatory Compliance Specialist for a temporary assignment of 6 months.

In this role, you will independently take responsibility for the regulatory verification and assessment of third-party products (3rd Party Products) with regard to the applicable European (EU-MDR / EU-IVDR) and Swiss regulations (MepV / IvDV).

Tasks & Responsibilities

• Regulatory Verification: Independent review and assessment of technical documentation, declarations of conformity (DoC), CE certificates and labelling of 3rd-party medical devices and in vitro diagnostics, as well as verification of correct labelling regarding CH-REP (Swiss authorised representative) and importer obligations according to MepV/IvDV.
• Vendor & Partner Management: Communication with suppliers and partners to request, review and clarify missing regulatory evidence and quality agreements.
• PRRC Support: Preparation of recommendations for the release or blocking of third-party products for the Swiss market.
• Operational support in the regulatory area as needed: including supplier inquiries and document review.

Must-Haves

• Successfully completed studies in medical technology, natural sciences, industrial engineering or a comparable qualification
• Proven, several years (3+ years) of professional experience in regulatory affairs / quality management in the medtech or IVD sector
• In-depth knowledge of EU-MDR (2017/745) and EU-IVDR (2017/746)
• In-depth knowledge of the Swiss Medical Devices Ordinance (MepV) and In Vitro Diagnostics Ordinance (IvDV)
• Practical experience in auditing, releasing or verifying supplier and third-party documentation (3rd-party processes)
• Fluent German and English, both spoken and written

Benefits

• Become part of one of the most renowned pharmaceutical companies and actively shape the future of healthcare
• Experience a corporate culture that promotes diversity and inclusion and where all employees feel valued
• Work on a state-of-the-art campus with green spaces, meeting zones and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative working environment
• Start with professional onboarding and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, parking facilities are available on site (according to internal guidelines)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive ongoing discounts on fuel with our fuel card

We value diversity and therefore welcome all applications - regardless of gender, social background, religion, age and identity. For easier readability and better understanding, we use only one gender form. Of course, all gender forms are equally meant in the respective context.

Contact
Kristof Wildmann

Workplace
Rotkreuz

Workload
100%

Position
Employee

Industry
Pharmaceuticals + Chemicals + Life Science