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Job description / Role
We are currently working with a leading medical device company to recruit a Turkish Regulatory Affairs Specialist to help develop regulatory strategies, perform activities associated with obtaining and maintaining regulatroy approval to commercialise medical devices in selected markets.
Responsibilities include:
- Structuring and managing regulatroy submissions
- Maintain an excellent understanding of global medical device regulations in accordance with ISO13485 as required
- Responsible for product registration in Turkey and other markets as appropriate
- Ensure device labelling is correct and they they meet all regulatory requirements
- Plans and prepares regulatroy submissions for new products, product changes and re-registrations for specific countries / regions
- Maintain all registration information and obtain re-registration approvals in advance of license expirations
- Perform translation activities as needed
- Coordinate multiple projects at one time and provide regular reports to management
- Perform additional duties as assigned.
Requirements
- Previous Regulatory Affairs Specialist experience in Turkey
- At least 5 years experience in related industry
- Be able to communicate in Turkish and English - written and verbal
- High self-motivation
- Good computer skills including Microsoft Office
- Thorough knowledge of relevant regulatory requirements.
About the Company
At Hays, we invest in lifelong partnerships that empower people and businesses to succeed. With over 50 years’ success under our belts and a workforce of 10,000+ people across 32 countries, we’ve evolved to put our customers at the heart of everything we do.
So much more than a specialist recruitment business, what really sets us apart is our knowledge through scale, deep understanding and our ability to meaningfully innovate for our customers. By providing advice, insights and expertise on issues you face today in the fast-paced world of work, we help you make the right decisions for tomorrow.
Offering an unrivalled suite of recruitment and workplace solutions, whether you’re looking for what’s next in your career, or have a gap to fill, we’ll help you get where you want to go.
You can rely on us to deliver today and help you plan for tomorrow.