Regulatory Affairs Specialist

Are you passionate about navigating global regulatory landscapes for innovative
medical devices? Do you thrive in a fast-paced, entrepreneurial environment?

We are seeking a Regulatory Affairs Associate to drive compliance and regulatory
submissions worldwide for state-of-the-art medical technologies. This is an exciting
opportunity to collaborate with cross-functional teams and ensure adherence to the latest global standards and regulations.

What you’ll do:

• Manage regulatory submissions, including CE mark, FDA, and global filings.
• Maintain compliance with ISO 13485, ISO 14971, EU MDR, US 21 CFR 820, and
  MDSAP.
• Provide strategic regulatory insights during product development.
• Support audits, post-market surveillance, and risk management activities.

What we’re looking for:

• Bachelor’s degree in Engineering or Science with 4+ years in medical device
  regulatory affairs.
• Proven experience in EU MDR and US FDA regulations (certifications desirable).
• Exceptional project management and organisational skills.
• Self-motivated team player with excellent communication skills.

Join a team dedicated to improving patient outcomes and shaping the future of
medical technology. If you’re detail-oriented, proactive, and eager to make an
impact, we want to hear from you!

Apply now to take the next step in your regulatory career.