Manager Quality Assurance and Regulatory Affairs
Rhinomed AB / Organisationsutvecklarjobb / Stockholm
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hela Sverige Visa alla jobb hos Rhinomed AB i Stockholm Rhinomed is a research-based medical device company in expansion. Our technology targets the nervous system of the patient and we develop researched based clinical non-invasive devices for multiple indications. Our aim is to help patients with chronic diseases to a better life.
Rhinomed is currently looking for a Quality Assurance and Regulatory Affairs manager to help us transform clinical science to patient treatments using new technologies and products. The technology and products we provide our customers with is the core, however it is the people of Rhinomed that make it happen.
If you want to push the boundaries of medical technology and appreciate a workplace that is challenging, energizing, and rewarding, we hope you?ll consider joining us.
Rhinomed is ISO 13485 certified and have one CE-marked product.
The Quality Assurance and Regulatory Affairs manager will ensure that Rhinomed products and procedures comply with regulatory agencies, and is responsible for developing and maintaining quality assurance procedures and controls.
Major Responsibilities:
• Identify opportunities to proactively assure compliance to applicable quality regulations
• Develop a Quality Assurance and Regulatory Affairs strategy
• Maintain and optimize our quality system (according to ISO 14155 and ISO 13485)
• Support the Clinical, Marketing, R&D and Operations departments in quality and regulatory matters
• Prepare appropriate documentation for CE mark certification
Experience & Training:
• Relevant Master?s degree or equivalent
• Minimum 5 years? experience from relevant positions in the medical device industry
• Experience from development of medical devices conforming to the Medical Device Directive and applicable standards (for example ISO EN 60601-1, ISO 14971 and 14155)
• Experience with FDA medical device regulations is an advantage.
The position is full time and based at our office centrally located in Östermalm, Stockholm.
Visit
www.rhinomed.com to learn more about Rhinomed AB. If you have any questions please contact Jan Hermansson, on +46 (0) 708-467054 or at
jan.hermansson@rhinomed.com .
You are welcome to send your application to
jobs@rhinomed.com .
Please apply no later than 2012-10-31.
Publiceringsdatum2012-09-26Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2012-10-31
Ansökan kan skickas till e-postadress:
jobs@rhinomed.comFöretagRHINOMED AB
AdressRHINOMED AB
BOX 24002
10450 STOCKHOLM
KontorsadressKARLAVÄGEN 108
STOCKHOLM
Övriga kontaktuppgifterTelefonnummer: 08-40011586
E-postadress:
jobs@rhinomed.com Jobbnummer 1350425
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