Regulatory- och kvalitetssystemsansvarig

Brighter Ab (publ) / Organisationsutvecklarjobb / Stockholm
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To ensure international acceptance of the company as a reliable manufacturer of medical technology
products by establishing the compliance of the company?s products and processes to external
health and safety regulations on the markets which the company will enter with its products, as
well as to ensure measurable savings/increased revenues by providing consistency in the company?s
operations, the role undertakes the following general responsibilities:

Overall compliance planning: prioritize the compliance activities in accordance with the
company?s strategic and actual goals;

Plan and lead the projects aiming at obtaining market clearance/approval in Europe, USA
and other markets of interest (CE-marking, 510(k) pre-market notification, etc.);

Plan and lead the project aiming at development, implementation and maintenance of
quality management system which shall support the company?s operations as well as acts as
an evidence of their conformity to regulatory requirements;

Plan and lead the project aiming at development and implementation of risk management
process throughout the product life cycle;

Ensure risk-based management of the company?s suppliers and subcontractors;

Develop and implement post-market surveillance process.

Experience with our own system is a must.

Publiceringsdatum
2012-12-17

Arbetstider och omfattning
Tillsvidare
Heltid

Ersättning
Fast lön

Så ansöker du
Ansökan kan skickas till e-postadress: appl@brightercompany.com

Företag
BRIGHTER AB (PUBL)

Adress
BRIGHTER AB (PUBL)
Box 2344
10318 STOCKHOLM

Kontorsadress
Munkbron 11
STOCKHOLM

Övriga kontaktuppgifter
Telefonnummer: 08-55008820
E-postadress: appl@brightercompany.com

Jobbnummer
1418968

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