Regulatory Affairs Specialist - medical devices

About this vacancy

Do you want your work to have a direct impact on patients around the world? Join a global MedTech organization dedicated to advancing innovative solutions that make cancer treatment more precise, effective, and accessible.

As a Regulatory Affairs Engineer, you will play a critical role in bringing innovative medical devices to market. Working closely with both local and international teams, you will ensure compliance with regulatory requirements while helping to drive quality, efficiency, and continuous improvement across the organization.

Your responsibilities:

• Prepare, compile, and submit regulatory documentation to health authorities and regulatory bodies;
• support global market access activities for a portfolio of innovative medical devices;
• collaborate with cross-functional teams, including Engineering, Quality, and Product Management, to assess regulatory impacts and define compliant processes;
• review, approve, and maintain regulatory documents, records, and submissions;
• plan, coordinate, and execute internal and external audits, including audit reporting and follow-up activities;
• develop, implement, and continuously improve regulatory procedures and working methods;
• monitor regulatory developments and translate requirements into practical business solutions;
• provide accurate project updates and regulatory guidance to stakeholders;
• drive continuous improvement initiatives that enhance compliance, quality, and operational effectiveness;
• proactively identify risks, solve complex challenges, and support organizational change initiatives;
• uphold the highest standards of quality, integrity, and regulatory excellence.

What we expect from you

• Minimum of 5 years of experience in Regulatory Affairs, preferably within the medical device industry;
• proven experience with regulatory submissions and project management;
• Master’s degree in Engineering, Life Sciences, Biomedical Sciences, or a related field;
• strong knowledge of global medical device regulations and compliance requirements;
• experience in supporting, coaching, or mentoring colleagues;
• excellent verbal and written communication skills in English;
• proactive, structured, and detail-oriented;
• committed to quality, compliance, and integrity;
• driven to continuously improve processes and drive positive change;
• creative in solving complex regulatory and business challenges;
• comfortable working in a dynamic, international environment and collaborating across teams

What you can expect from us

TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world. At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career. As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.