Compliance Manager
Thermo Fisher Scientific / Kemiingenjörsjobb / Uppsala
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Uppsala,
Östhammar,
Sigtuna,
Österåker,
Håbo eller i
hela Sverige Visa alla jobb hos Thermo Fisher Scientific i Uppsala,
Stockholm,
Huddinge,
Göteborg,
Ängelholm eller i
hela Sverige Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit
www.thermoscientific.com/phadiaCOMPLIANCE MANAGER
Reports To: Director, Global Quality Assurance & Environmental Management (QA& EM)
Position Location: Uppsala, Sweden
Number of Direct Reports: 0
Position Summary:
As compliance manager you are responsible for ensuring compliance of regulatory directives and standards applicable to the medical device and in vitro diagnostic industries as relevant for all markets being served. This position defines reviews and implements new and updated quality and environmental standards, laws and regulations, working closely with the entire organization to ensure compliance. This position will also act as a regulatory Auditor, arranging for site self-inspections and conducts external supplier audits. The position reports to the Director Global QA & EM.
Key Responsibilities:
• Ensure compliance with medical device and in vitro diagnostic regulations, directives and standards
• Be the Chairman for the Compliance Board, actively driving decisions for updating the Quality Management System to always reflect current and relevant regulatory directives and standards
• Design and maintain the information flow model for how to effectively gather, distribute and evaluate updates and new regulations coming
• Establish the collaboration between the divisional and group level QA/RA teams, and participate in global network groups as applicable
• Be well versed in and constantly keep yourself up-to-date on applicable regulations, guidelines and standards
• Plan and perform proper communication and company-wide training related to applicable regulations
• Maintain electronic files of inspections and certifications
• Complete requests for Vendor/Supplier Questionnaires
• Perform internal inspections according to plan
Requirements/Qualifications:
• University degree in medical/technical sciences
• Minimum of 5 years in a medical regulated industry
• Experience from quality and environmental management systems in an IVD/Medical device environment, e.g. QSR, EU medical directive, ISO 13485, ISO14001, ISO14971, etc.
• Significant experience in analyzing and interpret regulations, directives and standards
• Experience in managing internal inspections
• Excellent verbal/written communication skills; fluency in Swedish and English preferred.
Personal skills:
• Creative, with analytical problem solving skills
• Enjoy leading cross-functional groups working through complexity
• Ability to influence others, fostering integrity and being persistent
• Putting pride in finding efficient ways of implementing new and updated standards
• Strong Communication skills
• Complete finisher
For further information please contact:
Kristina Berglund, Global QA & EM +46 18 16 38 90
Annika Berg, Vice President, Global QA, RA & EM +46 70 982 99 20
Hanna Hardenborg, Manager HR +46 18 16 34 45.
Publiceringsdatum2015-02-13Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duPlease send your application with CV and marked reference no. 21 to
hr.idd@thermofisher.com no later than March 1, 2015.
Ansökan kan skickas till e-postadress:
hr.idd@thermofisher.comFöretagThermo Fisher Scientific
AdressThermo Fisher Scientific
Box 6460
75137 UPPSALA
KontorsadressRapsgatan 7P
Övriga kontaktuppgifterTelefonnummer: 018-165000
E-postadress:
hr.idd@thermofisher.com Jobbnummer 2165879
Observera att sista ansökningsdag har passerat.