Our client is one of the leading players in the medical devices manufacturing sector. Due to business needs, they are now recruiting a Regulatory Affairs Specialist to be part of their Quality team for ongoing transformation projects. They are located in the east.
The Regulatory Affairs Specialist's responsible is:
- Provide regulatory strategy and guidance to support product development, submissions, and timely market launches
- Prepare and manage regulatory filings (e.g. US FDA 510(k), EU MDR Technical Files/Design Dossiers, and global registrations)
- Coordinate submissions, renewals, and variations with global regulatory authorities to ensure ongoing market access
- Monitor regulatory changes, assess impact, and advise stakeholders on compliance requirements
- Maintain product registration database and track submission status, approvals, and renewals
- Support regulatory compliance across the full product lifecycle (development to post-market)
- Ensure adherence to US FDA, EU MDR, and other international medical device regulations
- Handle Medical Device Reporting (MDR), vigilance reporting, and support field safety corrective actions (e.g. recalls)
- Perform other regulatory or project-related duties as assigned
Job Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, Biomedical Science, or a related field Experience
- Min 4 years of regulatory affairs experience in medical devices.
- Familiar with FDA product registration and ISO 13485
Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.
We regret that only shortlisted candidate will be notified.
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