Regulatory Affairs Associate (m/f/d) 100%

BÜHLMANN Laboratories AG

Schönenbuch

Key information

Publication date:24 July 2025
Workload:100%
Contract type:Unlimited employment
Place of work:Schönenbuch

Job summary

Join BÜHLMANN Laboratories AG, a leader in diagnostics! Be part of a supportive team.

Tasks

Support international registration of diagnostic products.
Coordinate technical documents and ensure quality consistency.
Assist in regulatory processes and manage documentation.

Skills

Scientific education in Biology, Biochemistry or similar.
Experience in Regulatory Affairs and document management.
Strong communication skills and a team-oriented mindset.

Is this helpful?

Together we shape the future of diagnostics - become part of our team! BÜHLMANN Laboratories AG is an international production and trading company in the field of Life Sciences based in Schönenbuch, Canton of Basel-Landschaft. For 49 years, we have developed leading in-vitro diagnostic products (IVD) that hospitals and private medical laboratories trust worldwide. We employ over 150 staff, 140 of whom are in Schönenbuch. To strengthen our Regulatory Affairs team, we are looking for a dedicated personality as Regulatory Affairs Associate (m/f/d) 100%. In this varied role, you will support the international registration of our products, coordinate technical documents, and contribute to the quality and consistency of our product documentation. You will report directly to the VP Regulatory Affairs. Your tasks

Management and maintenance of technical product documentation (IFUs, technical flyers, MSDS, etc.) according to internal SOPs
Coordination of translations, versioning, layout, and filing of documents
Support in national and international registration processes
Preparation of approval documents and obtaining certifications (including Free Sales Certificates)
Monitoring and renewal of existing approvals
Ensuring consistency of all content across different document types
Participation in the maintenance of the quality management system (SOPs)
Collaboration with the Development, Global Marketing, and external partners
Creation of supporting illustrations (e.g., for instructions for use)

Your profile - What you bring

Scientific education (HF/FH) in biology, biochemistry, or comparable
Initial experience in Regulatory Affairs, document management, or a similar role is an advantage
Further training in Quality Assurance / Regulatory Affairs is an advantage
Knowledge of IVD regulations and ISO 13485 is an advantage
Very good German and English skills, both written and spoken
Proficient in MS Office; experience with Adobe InDesign & Illustrator is an advantage
Accurate, independent working style with a high quality standard and a flair for design
Team player with strong communication skills and organizational talent

What you can expect from us

A responsible role with development potential in a future-oriented company
A collegial team that supports you and grows with you
Modern infrastructure at the headquarters in Schönenbuch - with the possibility of home office
Flat hierarchies, short decision-making paths, and an innovation-friendly environment
Attractive employment conditions and individual training opportunities

Ready to bring your expertise into a dynamic environment and make a big impact? Then become part of our team - we look forward to your application! Please send your complete application documents for confidential review by email to career@buhlmannlabs.ch Direct applications are preferred. No agencies please. BÜHLMANN Laboratories AG, Attn: Human Resources, Baselstrasse 55
CH-4124 Schönenbuch