Compliance Manager/PRRC with a Passion for Regulatory Expertise

Do you want to be a key person in a dynamic company that specializes in medical textiles within post-op bras, ostomy, incontinence, wound care and more, where you can both dive into the world of legislation and lead interdisciplinary projects? Are you a detail-oriented person who loves to sniff out new regulations and ensure that Tytex always is ahead of the curve? Then you might be the one we are looking for!

Tytex is seeking for a dedicated Compliance Manager/PRRC who not only has a keen eye for details, but also a burning interest in staying updated on relevant regulations and standards - in the field of medical devices, sustainability, and other legislations. You will play a central role in ensuring that Tytex always is in compliance with both national and international regulations.

Your Primary Responsibilities:

• Regulatory Monitoring and Updating: Proactively track and with your analytical capability monitor changes in legislation, standards, and regulatory requirements across areas
• Global Regulatory Consistency: Manage and maintain required regulatory submissions and registrations for Tytex devices in all relevant markets, including the EU, US, Middle East and other key markets. You will with your excellent interpersonal ability collaborate with international regulatory partners to ensure compliance with all relevant standards
• Project Management and Interdisciplinary Collaboration: Drive and implement regulatory projects across multiple departments. You will lead initiatives e.g. CSRD, GPSR and more, that require input from various teams with the use of your powerful communicative skills
• Documentation and Customer Agreements: Prepare, maintain, and ensure accurate documentation for Tytex devices. Additionally, you will oversee and manage customer agreements, ensuring that contractual obligations are met and aligned with regulatory requirements

The position is full-time, 37 hours per week, and you will be based at the company’s headquarters in Ikast.

Who Are You?

• You have a master’s degree within law, engineering, natural sciences, or a similar relevant education and at least one year of experience with regulatory work or quality management in medical devices.
• Or you have at least four years of experience with regulatory work or quality management in medical devices.
• You have an in-depth understanding of Medical Device Regulation (EU) 2017/745, ISO 13485, ISO 9001, ISO 14001, ISO 14971
• You thrive in the ambiguity of regulations, have a passion for understanding complex regulatory requirements and are confident in making strong legal decisions based on Tytex’ strategy
• You have strong project management skills and can drive projects from start to finish, with a focus on both quality and deadlines
• You have powerful communication skills and can convey complex regulations in an understandable way to colleagues across the organization

What to expect as a member of Tytex:

• A salary package including a fixed monthly salary as well as pension, health insurance and flexible wage account. You will also have the opportunity to join a good canteen and staff association
• An exciting and versatile role in a growing company where you can make a difference
• The opportunity to work with various aspects of compliance, from medical devices to sustainability
• A dynamic and professionally inspiring work environment where your curiosity and passion for legislation are valued
• You will be a part of the Tytex Compliance Team, and you will report to the Head of Medical and Regulatory Affairs, Ina Nemes

About Tytex

Tytex is a Danish textile company with expertise in medical textiles. Tytex develops, manufactures and supplies innovative products for the healthcare sector. Tytex focuses on developing products that maximise comfort and freedom of movement while meeting the essential needs of both patients and healthcare professionals. Tytex is committed to sustainability and social responsibility and has implemented a number of initiatives to minimise environmental impact. Tytex is uniquely positioned in this textile niche and sells its products on four continents.

Being an international, leading healthcare group with the headquarter in Denmark, Tytex employs over 600 people in Denmark, The United States, The United Kingdom, Germany and Slovakia. The production takes place in Slovakia.

See more at: www.Tytex.com

Application and contact

We encourage everyone to apply regardless of gender, age, ethnicity, religion, sexuality or disability. To ensure a fair recruitment process, we ask you not to include a picture of yourself when applying.

Please send your motivated CV as soon as possible to PRO&CO via the button “Søg stillingen” below. PRO&CO is handling the recruitment process for Tytex.

Applications are reviewed on an ongoing basis, and the position will be filled once the right candidate is found.

If you have any questions about the position, feel free to contact:
Jannie Dybdal – PRO&CO – at +45 31 45 86 46 or as well by email at [email protected]