Specialist Quality Assurance, Regulatory Affairs Management

Senior Specialist Quality Assurance, Regulatory Affairs, and Work Environment Management

ZEISS is an internationally leading technology enterprise operating in the fields of optics and optoelectronics. The ZEISS Group owned by the Zeiss Foundation with its rich history, develops, produces and distributes measuring technology, microscopes, medical technology, eyeglass lenses, camera and cinema lenses, binoculars and semiconductor manufacturing equipment. With its solutions, the company constantly advances the world of optics and helps shape technological progress.

The ZEISS Group is represented in more than 40 countries and has over 50 sales and service locations, more than 30 manufacturing sites and 25 R&D centers around the globe.

In the Nordics, ZEISS has direct sales and service representation in all four countries and employs a network of Account Managers, Product and Applications Specialists and a strong Field Service team. We are 195 skilled employees in the Nordics with the main hub located in Stockholm.

Your Role

We are seeking a highly skilled Senior Specialist to lead Quality Assurance (QA), Regulatory Affairs (RA), and Work Environment Management at ZEISS Nordics. The role requires strong expertise in quality and regulatory management, environmental compliance, and corporate governance.

The purpose of the role is to ensure that ZEISS Nordics, a sales and service organization across Sweden, Norway, Finland, and Denmark, complies with all applicable quality and regulatory requirements. The role will also drive the continuous development of these areas and act as the key interface to ZEISS global headquarters in Germany, while leading local hands-on improvement initiatives.

In this role, you will report to the CEO of ZEISS Nordics, collaborate closely with the senior leadership team, and contribute to global initiatives across Quality, Regulatory, and Health & Safety within the ZEISS Group.

The role Specialist Quality Assurance, Regulatory Affairs and Work Environment Management of will involve:

• Maintain, develop, and evaluate the ZEISS Nordics Quality Management System across all Nordic sites.
• Act as Management System Officer, ensuring alignment with corporate standards and ISO standards (ISO 9001, ISO 14001, ISO 13485) and implement required changes in close alignment with CEO and CFO.
• Serve as Nordic responsible for HQ Regulatory Affairs Medical Technology in close alignment with the Head of Medical Technology in Nordics.
• Align regulatory activities with the Go-to-Market Plan and drive the process of bringing new products to the Nordic market in line with MDR and applicable local regulatory requirements.
• Monitor regulatory changes and manage country-specific regulatory obligations for medical devices.
• Act as Environmental Officer and conduct and oversee required monitoring, reporting, and documentation in line with environmental standards.
• Support identification and evaluation of environmental risks across Nordic sites.
• Provide expert guidance on environmental compliance and sustainability requirements.
• Act as Occupational Health and Safety Officer for the Nordics in close alignment with head of HR.
• Support to assure and drive implementation that our entities/sites adhere to all relevant health and safety legislation such as international and local legal requirements.

As a Specialist Quality Assurance, Regulatory Affairs and Work Environment Management you will have:

• Experienced QA/RA professional (5–10+ years), ideally within a sales and service company acting as distributor across the Nordic countries
• Strong understanding of the Nordic regulatory landscape and work experience within the medical technology industry
• Strong knowledge of ISO standards (9001, 14001, 17025) and regulatory frameworks
• Passion to work independently and solution-oriented in a pragmatic way
  • Hands-on experience with audits, certifications, and compliance (incl. work environment & occupational health and safety)
• Ability to lead improvement initiatives in complex organizations
• Strong communicator with a cross functional collaborative, "get-things-done" mindset
• Experience working with senior leadership and change management
• Fluent in English and Swedish, additional Nordic languages are beneficial

Apply now to take the next step in joining ZEISS, where you can push technological boundaries, shape markets and contribute to the advancement of society.