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 organizational 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.
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