Regulatory Affairs Manager - Systems

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 90,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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 working with these products, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics. Together there are 90 000 employees working for Thermo Fisher Scientific globally.

How will you make an impact?
Do you have an eye for detail and enjoy analysing and interpreting information? Are you positive, structured, and keen to drive towards better ways of working? Is it important for you to work with products that will have a positive impact on peoples’ lives?
In this role as Regulatory Affairs Manager, you will be part of a professional and engaged Regulatory Affairs team, analysing regulatory requirements in different geographies, connecting this to product documentation, and ensuring that our products conform to local requirements.
You will be working cross-functionally and globally with market authorizations of diagnostic products, which help people with allergies and autoimmune diseases to live healthier lives.
You will be a key player in business-critical projects, developing regulatory strategies, GAP analyses, regulatory assessments, and working tightly together with regional Regulatory Affairs managers, as well as internal colleagues, to ensure compliance for our instruments, software’s and systems.

What will you do?
· Manage and coordinate regulatory activities to ensure compliance of existing products on current or new global markets
· Be one of the SME´s for instruments and software products
· Define and implement registration strategies
· Participate in product registration projects on defined global markets, including defining regulatory requirements, supporting the project team with regulatory expertise, working closely with regional regulatory affairs managers, as well as compilation and submission of required documentation to support market authorizations
· Contribute to improved routines and processes for the Global Regulatory Affair’s team.


What do you need?
• Previous experience within the medical device or diagnostic industry in a regulatory affairs related role is preferred
• Good knowledge and work experience of ISO 13485
• Strong communication and problem-solving skills are essential, you should be someone who works well in a team and is comfortable working within a matrix organisation, and cross functions
• As a person you are flexible and confident working in an ever-changing environment
• Fluent Swedish and English, both spoken and written
• We believe you work with a focus on accuracy, clarity and timely deliveries


Please send in your application, including a cover letter, CV (in one document) in English, apply via http://jobs.thermofisher.com/ by 6th December 2021. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.
If you have questions, then please contact:
Nina Albuquerque, Sr Recruiter Nordics: nina.albuquerque@thermofisher.com
Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age.