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

About the job

We are looking for an immediate start or by arrangement for a

Regulatory Affairs Specialist

m/f/d (100%)

As a Swiss family business with a 160-year history, we at SIGVARIS GROUP employ more than 1600 people worldwide. We are committed to ensuring that people feel good every day with high-quality and innovative offerings in the field of medical compression therapy. Our portfolio covers a wide range of needs and indications. Continuous development and innovation, as well as a consistent commitment to solutions that support our customers in all their activities, make us the preferred partner for all involved. At SIGVARIS GROUP, we have made it our mission to create an excellent working environment for our most valuable asset, our employees. Their talents, diversity, and commitment are crucial to our innovative strength and success

In this role, you contribute to ensuring the regulatory compliance of our medical devices and create the necessary conditions for their development, manufacture, marketing, and distribution at national and international levels. You support the continuous development of our quality management system and accompany our products throughout their entire regulatory lifecycle.

Your responsibilities include:

• Maintenance, development, and implementation of the quality management system according to ISO 13485
• Creation and approval of quality and regulatory documents as well as technical documentation according to MDR (EU) 2017/745
• Planning and support of internal and external audits, inspections, and conformity assessments
• Vigilance, post-market surveillance, product registrations, and regulatory review of product changes
• Support in risk, CAPA, and deviation management as well as advising internal stakeholders and liaising with authorities and notified bodies

Your profile:

• Completed training or bachelor’s degree in medical technology, natural sciences, engineering, quality management, or comparable
• Initial experience or internships in quality management, regulatory affairs, or a regulated environment
• Basic knowledge of ISO 13485 and MDR as well as experience with technical or quality-relevant documents
• Fluent German and English skills, both written and spoken; confident use of MS Office; experience with document or QMS systems is an advantage
• Careful and reliable working style, willingness to learn, quality awareness, and strong communication skills

Our offer:

• Being part of an international company and contributing with varied tasks to making people feel good every day.
• Independent work with plenty of room for personal and professional development
• Stable family business with strong market and value orientation
• Competitive salary & benefits as well as excellent insurance coverage
• Flexible working model, including the possibility of home office

Are you interested in this exciting job?
Then send us your application documents.

Apply now

SIGVARIS AG - Gröblistrasse 8 - 9014 St. Gallen