Regulatory Affairs Manager
Neoss AB / Ekonomichefsjobb / Härryda
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In the middle of an exciting period of growth and investment, Neoss is seeking a Regulatory Affairs Manager for our facility in Mölnlycke. The Regulatory Affairs Manager defines and manages all regulatory aspects of projects and medical device submissions to Health Authorities worldwide. The ideal applicant for this position enjoys integrating business objectives with regulatory requirements. We are looking for an enthusiastic, self-motivated, highly organized and flexible person to join the team on a full time basis.
The key areas of accountability are pre-market activities such as:
• Monitor and implement new regulations and change in existing regulations and advice internal process owners in order for Neoss to be compliant with regulations on a worldwide basis.
• Consult with and advice the necessary internal functions in order to achieve CE marking, FDA clearances and other such as special requirements in Asia/Pacific.
• Be the Regulatory Affairs responsible in projects delivering New product development, Line extensions and upgrades according to product launch plans.
• Be the Regulatory Affairs consultant and coordinator supporting Operations, Development and Quality Assurance in order to build and mentor best practice
• Create, review and approve documents necessary for achieving product approvals and marketing claims.
Experience:
• You must have experience from the Medical Device Sector - preferably with Dental Implants - for at least 8 years and including 5 years of Regulatory Affairs experience. Preferably you should have a university degree, or equivalent, in Biology, Engineering or a related subject, or a solid product development experience with interest and ambition to focus further on regulatory affairs
• Experience from working in an international environment using English on a daily basis, both orally and written, is a prerequisite.
• In order to succeed in this role you must remain up to date with new and changing regulations. You are a good organizer and you do have the ability to establish fruitful relationships and maintain networks, as you will be the link between our internal departments, authorities and external partners.
• You have detailed knowledge about Technical Files and preferably experience in writing reports related to Regulatory submissions including initiating and coordinating market specific testing and validation activities
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-05-09ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-05-29
Klicka på denna länk för att göra din ansökanAnge följande referens när du ansöker: N1403
Ansökan kan skickas till e-postadress:
jobb@neoss.comFöretagNEOSS AB
AdressNEOSS AB
MÖLNLYCKE FABRIKER 3
43535 MÖLNLYCKE
KontorsadressMÖLNLYCKE FABRIKER 3
MÖLNLYCKE
Övriga kontaktuppgifterTelefonnummer: 031-881280
Jobbnummer 2833170
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