Regulatory Affairs Expert Medical Device Approval - Focus USA

Your job in medical technology - at a global market leader, start-up and family business all in one. 

PAJUNK® is an owner-managed family business with around 700 employees worldwide and is headquartered in Geisingen, southern Germany. We develop needs-orientated medical products with the aim of enabling medical professionals worldwide to focus on what really matters: the patients.

We combine the strength of a market leader with the agility of a start-up. You will benefit from a secure job with innovative products in a crisis-proof industry and an international environment. In addition, you can expect short decision-making processes and respectful cooperation, so that real teamwork is possible.

Support our team from 01.07.2025 as a Regulatory Affairs Expert for Medical Device Approval with focus on the USA.

Your tasks

• You will be responsible for the approval of our new and existing products in the USA to ensure that they are launched on time and in compliance with regulations. This includes the strategic planning and coordination of approvals as well as the creation and submission of approval files via eStar (e.g. 510(k)).
• By maintaining regulatory and product databases (FURLS) and supporting our US Agent and Official Correspondent, you will ensure that all registration data is always up-to-date and legally compliant.
• You will also assist with UDI management (GUDID) to ensure complete product labelling and identification. 

• You will also monitor regulatory developments and work with the specialist departments to ensure that legal requirements are implemented.

   

What you bring with you

• Ideally a degree in engineering, natural sciences, human medicine, medical technology or life sciences
• Initial professional experience in regulatory affairs/authorisation is an advantage
• Proactive way of working with an eye for efficient solutions
• Communication skills and enjoy working with open-minded colleagues from your team and neighbouring departments

• Very good written and spoken German and English skills

   

You can look forward to

• Varied tasks and the opportunity to help shape future-relevant projects
• A modern working environment and openness to new technologies
• An attractive salary package (Christmas and holiday bonus, voluntary performance bonus, travel allowance depending on distance travelled)
• A comprehensive health and sports programme (ergonomic workstations, company sports, Hansefit, health days, company doctor, free vaccinations)
• Seasonal and delicious food, freshly prepared by our kitchen team
• Find out more about our numerous benefits here