Regulatory Affairs Specialist / Regulatory Affairs Specialist

About the Role

For our client, a major multinational company, we are seeking a Regulatory Affairs Specialist to join their team. In this role, you will manage regulatory compliance and the product lifecycle of medical devices within a global framework. You will collaborate closely with R&D and Marketing teams across Switzerland, the US, and Japan to ensure successful market access.

Your primary focus will be to ensure that all medical devices comply with international regulations while managing technical documentation and communication with health authorities throughout the product lifecycle.

This is an amazing opportunity not to be missed!

Apply Online

Apply online using the form below. Please note that only applications matching the job profile will be considered.

Work Tasks

• Compile and submit regulatory dossiers and technical files to notified bodies and international partners.
• Ensure documentation and processes meet Medical Device Regulation (MDR) requirements.
• Manage the regulatory lifecycle of products from development through to market launch.
• Perform regulatory impact assessments for product modifications via change control processes.
• Review and approve promotional materials and labeling to ensure regulatory compliance.
• Manage Materiovigilance reporting and update the EUDAMED database (UDI implementation).
• Support audits and inspections by providing required documentation to health authorities.

We Are Looking For

• Experience in regulatory affairs within the medical device or pharmaceutical industry.
• Advanced knowledge of Medical Device Regulation (MDR).
• Fluent English (C1 level).
• Immediate availability.
• Trustworthy, stress-tolerant, goal-oriented, and sociable.

Our Recruitment Process

This recruitment process is managed by Academic Work, and all inquiries regarding the position should be directed to them. The selection process is continuous, and the advert may close before the recruitment process is completed if we have advanced to the next phase. The process includes two tests: a personality test and a cognitive test, which serve as tools to find the right talent for the right position, ensuring equality, diversity, and a fair process.

Join Academic Work

When you apply for this position, you will become part of the many consultants at Academic Work. You will enjoy numerous benefits and have a Consultant Manager team to support you at this stage of your career.

Questions About the Position?

For any inquiries, please contact the recruitment team at info@academicwork.ch and include the job ID ZHVFS6 in your email.