Editorial summary

The company, a leading manufacturer in the medical devices sector, is seeking a Regulatory Affairs Specialist to join their Quality team and support ongoing transformation projects. The role involves providing regulatory strategy, preparing and managing submissions such as US FDA 510(k) and EU MDR dossiers, and coordinating filings and renewals. Candidates should have relevant experience in medical device regulations and compliance. The position offers a salary of 7,000.

This summary is AI-generated and may contain inaccuracies. Please refer to the full job description below.

Job description

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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