Product Compliance Manager
Phadia AB / Administratörsjobb / Uppsala
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hela Sverige Thermo Fisher Scientific is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life science research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
This position is based in Uppsala, where Thermo Fisher develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,900 employees worldwide, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.
How will you make an impact?
We currently have an opportunity for a Product Compliance Manager within the Product Stewardship team. The team supports IDD to have compliant products and related processes in place to meet applicable laws, regulations and standards and thereby attain and maintain global market access. The function consists of Product Compliance Managers, who lead cross functional product compliance activities and Subject Matter Experts within eg the UDI process.
What will you do?
Govern and maintain the UDI (Unique Device Identification) process.
Map out country/region specific product information data requirements for the Product Portfolio and coordinate data gathering with data owners.
Contribute as the UDI subject matter expert in product development and product care projects and in governance forums.
Support the organization to work in line with the Product Compliance process steps.
Lead product compliance activities
Synchronize actions to secure compliance with applicable requirements.
Develop and improve procedure, instructions, templates and routines as required
Develop and maintain training material.
Build and maintain internal and external networks to ensure state-of-the-art deliverables.
Monitor and report KPI.
Act as the Subject Matter Expert in the UDI-process in audits
How will you get there?
The role suits someone who is flexible and able to quickly adapt to new situations. You are a motivated problem solver and a good collaborator. We hope you are a sociable person who communicates clearly and that you are proactive in the way you work. You are adaptable and able to analyse and re-prioritize tasks within short time frames depending on the organization's demands.
Qualifications:
A University degree or minimum of 3 years in a medical regulated industry
Excellent verbal/written communication skills; fluent in Swedish and English.
Strong Leadership capabilities, process and customer focused.
Strong interpersonal skills, driving cross-functional collaboration.
Ability to organize work, can decide about and reach objectives for the processes.
Strong ability to drive tasks/projects to closure in a timely fashion.
Experience working effectively in a cross functional environment and leading activities.
Apply today!
http://jobs.thermofisher.com , ref. R-01186770.
APPLICATION DEADLINE: 6th of August
If you have questions then please contact Petra Norrman, Recruiter Nordics,
petra.norrman@thermofisher.com.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Så ansöker du Sista dag att ansöka är 2023-07-27
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Phadia AB (org.nr 556041-3204)
Rapsgatan 7 (
visa karta)
751 37 UPPSALA
Arbetsplats Phadia AB
Jobbnummer 7918712
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