As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 17 billion in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives. At Thermo Fisher Scientific, each one of our 50,000 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.
In Finland we have over 700 employees in Vantaa and Joensuu. Our extensive range of products developed and manufactured in Finland includes pipettes, microplate instruments, magnetic particle processing systems as well as clinical chemistry and industrial chemistry analyzers and laboratory automation solutions. The Vantaa facility houses several different functions such as R&D, marketing, sales, service, logistics, quality as well as instrument and reagent manufacturing and is located close to the Vantaankoski railway station.
Thermo Fisher Scientific is a leading company in chromatography, high-resolution mass spectrometry, laboratory automation, microbiology, and specialty diagnostics. We are a multi-national team of experts developing a new exciting In Vitro Diagnostic (IVD) medical device/system. In order to strengthen our clinical microbiology instrument development team, we are now seeking for a
We are looking for a forward thinking RA Specialist with a background in biosciences, analytical chemistry or engineering. Ideally the Specialist has solid experience of international regulations and registrations of in vitro diagnostic devices. Experience in quality system regulations is beneficial. The selected candidate will work as an integral part of a multidisciplinary QARA team to secure conformance to regulations and to build registration packages to e.g. Europe, USA, China, Russia. Need to travel worldwide is at moderate level.
- To work as an integral part of a QARA team for Thermo Fisher’s Microbiology Division business
- Interpreting international IVD regulations and keeping local teams informed about them
- Secure timely implementation of regulations into new products and projects
- Execute activities in accordance with agreed schedules and budget
- Give training to local and international partners on related regulations
- Establish and maintain network of internal and external contacts for project collaboration
- Assess collaboration partners procedures for compliance for data creation
- Create written Standard Operating Procedures (SOP’s) together with collaboration partners
- Oversee and advice collaboration partners` activities during data creation
- Act as the independent reviewer of development documentation
- Act as Subject Matter Expert (SME) and advisor in area of expertise
The ideal candidate will have:
- M.Sc (or equivalent) degree in microbiology, biology, analytical chemistry, biochemistry or related science
- One to five years of experience in in vitro diagnostic regulations
- High proficiency with different regulations including quality system regulations for in vitro diagnostic products
- Skill set in conducting discussions with international partners
- Excellent verbal and written communication skills in English.
- Critical thinking skills and making contributions to the product development as part of a well-integrated team
- Attention to detail in setting, conducting, and documenting; record keeping in compliance with company policy and regulatory requirements (CEIVD and FDA QSR; ISO13485).
- Ability to communicate efficiently with the experts in the other scientific and technical fields, and a willingness to learn new skills.
- Ability to reach solution with confidence and integrity
- Sound organizational skills
- Must be able to multi-task
Bonus Qualifications (not explicitly required):
- Total Quality Management process experience
- Experience leading audits
- Associates or Bachelor of Science degree with Quality/Engineering focus
- Skills in applying various statistical principles to sample size determination and result assessments
What we offer you:
- A dynamic and friendly work environment
- A career in an international company and to be part of exciting projects to improve human conditions
- Get to work with the best teams in the industry, ranging from top-level scientists to cutting edge process- and production teams
- Competitive salaries
We look forward to receiving your application, including a cover letter and CV and a salary request in English. Please apply via http://jobs.thermofisher.com/. Reference: 50443BR. Please apply by Tuesday 27th of June, 2017.
If you have questions about Thermo Fisher Scientific and/or the position - please contact Quality Manager, Johanna Hakalahti at +358 40 037 3399 on 14th of June between 10-11 and 16th of June between 9-10.
At Thermo Fisher Scientific, each one of our 50,000 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.