Senior Regulatory Affairs Specialist - Medical Devices

Walker Cole International is searching for a Regulatory Affairs Specialist to join a global medical device company at their Munich site, focused on advanced wound care solutions.

As the Regulatory Affairs Specialist, your responsibilities will include:

• Supporting international regulatory submissions for wound care medical devices

• Acting as a key contact with notified bodies and supporting audits and reviews

• Preparing and maintaining technical files in line with MDR and ISO 13485 standards

• Collaborating with cross-functional teams to ensure regulatory compliance across product lifecycles

• Supporting global market registrations and liaising with regional regulatory partners

To be successful as the Regulatory Affairs Specialist, you will have:

• A degree in Life Sciences, Engineering, or a related field

• Experience in Regulatory Affairs within the medical device sector, ideally with wound care products

• Strong understanding of MDR and experience working with notified bodies

• Experience supporting international markets and global registrations

• Fluent English communication skills; German is a plus

Medical Devices | Regulatory Affairs | MDR | Notified Body | ISO 13485 | Wound Care | Global Submissions | Munich | Hybrid Working