Regulatory Affairs Manager
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Location
Berlin
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Sector:
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Job type:
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Salary:
Competitive
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Contact:
Leah James
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Contact email:
l.james@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
22 days ago
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Expiry date:
2021-03-11
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Startdate:
ASAP
Hamlyn Williams has partnered with a well known Medical device company in the Berlin area that is looking for a Regulatory Affairs Manager to join their team.
The role involves but is not limited to:
- Line management you will be managing a team of 4
- Supporting with internal and external audits (authorities, notified bodies)
- Registering the products in the selected markets
- Ensuring compliance to IS0 14971, ISO 9001 and ISO 13485
- Liasing with Regulatory and Quality contacts in EMEA to requirements for the region are met
As a Regulatory Affairs Manager you will need:
- Medical device background (experience with class 3 will be advantageous)
- Vast experience with Regulatory Affairs specifically FDA 510k submissions
- Risk management experience
- Line management experience
- Fluent in German
This is a rapidly expanding Medical Device company that offers an opportunity to work with life saving products. If you are interested in accelerating your career by choosing a management position it will be great to apply and we will get in touch with you shortly to discuss the position, company, and how we can help you.