Head of Regulatory Affairs 60-80%
Publication date:
01 April 2025Workload:
60 – 80%- Place of work:Bern
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Job summary
Join ARTORG, a leading research center at the University of Bern, focusing on medical technology. Enjoy a vibrant work environment with great benefits.
Tasks
- Develop regulatory processes for compliance with regulations.
- Lead preparation and submission of regulatory documents.
- Collaborate with teams to ensure regulatory needs are met.
Skills
- 5+ years in regulatory affairs in MedTech or pharma industries.
- In-depth knowledge of regulatory requirements (MDR, FDA, ISO).
- Excellent communication and interpersonal skills.
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ARTORG is a research excellence center of the University of Bern, dedicated to creating medical technology in the hub of Switzerland's capital. ARTORG has been delivering over a decade of ambitious biomedical engineering research, teaching, and development across a wide variety of clinical areas. Today, it is represented in twelve independent research groups – ranging from answering novel clinical challenges to improving existing approaches and medical technology with competences from pure algorithmic evelopments
across component and systems development all the way to clinical validation.
The University of Bern's ARTORG Center for Biomedical Engineering Research invites applications for a highly skilled and experienced Head of Regulatory Affairs to join our dynamic team and lead our regulatory strategy.
- Develop and implement regulatory processes to ensure compliance with local, national, and international regulations
- Lead the preparation and submission of regulatory documents
- Collaborate with cross-functional teams to support product development and ensure regulatory requirements are met.
- Monitor and interpret regulatory developments and communicate their impact to the organization.
- Provide regulatory guidance and support during audits and inspections.
- Minimum of 5 years of experience in regulatory affairs within the MedTech or pharmaceutical industry.
- In-depth knowledge of regulatory requirements and guidelines (e.g., MDR, FDA, ISO).
- Proven track record of successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced, collaborative environment
- A friendly, stimulating, international and multidisciplinary environment.
- A workplace in Bern, Switzerland's capital, known for its high quality of life and surrounded by beautiful nature, perfect for hiking, biking, swimming and winter sports.
Applications will be accepted until the positions are filled.
Interested candidates are invited to submit their resume and a cover letter detailing their qualifications and experience to Prof. Dr. Raphael Sznitman (E-Mail schreiben) with the subject “[Reg-003] Regulatory Affair”.
About the University of Bern
The University of Bern is in the heart of Switzerland. Internationally connected and regionally anchored, the University of Bern cultivates exchange with society and strengthens partnerships between science, medicine, business, and politics. The University of Bern is committed to a deliberate and ethical responsibility towards
people, animate and inanimate nature. It strives as an important educator, promoting enterprise and industry in the region and beyond, and distinguishes itself through problem-oriented research into questions of pressing social relevance.
The University of Bern is an equal-opportunity employer and strives to increase the number of women at all levels in its faculties.
