Head of Regulatory Affairs & Quality Management System m/f/d

About the job

We are looking for an immediate start or by arrangement a

Head of Regulatory Affairs & Quality

Management m/f/d

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. Because their talents, diversity and commitment are crucial to our innovative strength and success

Your tasks

• Professional and personnel leadership as well as further development of the local Regulatory Affairs team
• Ensuring regulatory compliance throughout the entire product lifecycle of our international medical device portfolio

• Development of regulatory strategies for new products, product changes and lifecycle management

  including technical documentation

• Ensuring compliance with the EU Medical Device Regulation (MDR 2017/745) as well as other relevant

  international regulatory requirements

• Responsibility for the quality management system, conducting internal and external audits as well as the

  continuous optimisation of regulatory processes and systems (ISO 13485)

• Responsibility for international product registrations and market approvals including

  conformity documentation

• Representation of the company towards notified bodies, authorities and international regulatory

  institutions

• Close cooperation with the departments Product Management, R&D, Quality Assurance, Operations, Marketing

  and Sales

• Support in the development and implementation of a global Regulatory Affairs strategy in cooperation

  with the global Quality & Regulatory team

• Monitoring regulatory developments and implementing new requirements in processes and

  product strategies in cooperation with the global Quality & Regulatory team

Your profile

• Completed university degree in natural sciences, medical technology, biomedicine, pharmacy or a

  comparable field

• Several years of professional experience in Regulatory Affairs for medical devices – experience with textile

  medical products (clinical textiles, wound healing, orthopaedics, …) is an advantage

• Proven leadership experience in an international corporate environment as well as enjoyment in

  developing high-performing teams

• Sound knowledge of the EU Medical Device Regulation (MDR 2017/745) is a prerequisite

• Experience in managing complex international approval and registration projects
• Strategic thinking, entrepreneurial action as well as a structured and solution-oriented way of working

• Strong communication and stakeholder management skills as well as the ability to collaborate successfully at all levels

  of an international company

• Fluent English skills; additional foreign languages are an advantage

What we offer you

• A strategic leadership position with high visibility within the corporate group
• The opportunity to actively shape the regulatory future of an internationally successful medical technology company

• An innovative, appreciative and international working environment with short decision-making paths

• Collaboration with committed experts worldwide

• Attractive employment conditions as well as diverse opportunities for professional and personal

  development

You have extensive experience in Regulatory Affairs for medical devices, know the requirements of the EU MDR and international approval procedures and want to shape regulatory excellence together in a global team? Then we look forward to meeting you.

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

Apply now

SIGVARIS AG - Gröblistrasse 8 - 9014 St. Gallen