Regulatory Affairs Specialist II

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Our work in specialty diagnostics – from providing diagnostic assays and instruments to clinical monitoring across disease stages – improves the diagnosis and management of blood cancers and immune system disorders. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.  

Location/Division Specific Information

The Binding Site Group, part of Thermo Fisher Scientific, is a global leader in specialty diagnostics, provides diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders.  The Binding Site’s Freelite® offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. In addition, The Binding Site is an active and influential contributor to the broader scientific community. To find out more visit www.bindingsite.com

Discover Impactful Work:

This is an opportunity to work as part of a dynamic regulatory affairs (RA) team (Post Market Surveillance (PMS) and vigilance) for the in-vitro diagnostics product range for sale in global markets.  Every day is different, providing the opportunity to make a difference and continuously learn.

A Day in the Life:

The role involves both proactive and reactive PMS activities including PMS review, improving procedures and addressing vigilance activities through attending risk meetings and reporting to competent authorities. In addition, RA representation in change control meetings will be expected alongside regulatory change assessments.

Keys To Success:

Education

• B.Sc. in Life sciences, preferably M.Sc. or higher in life sciences

Experience

• 2- 5 years in QA/RA roles in healthcare industry (medical devices or diagnostics) or 2- 5  years working in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent
• Experience of working in teams in a regulated industry
• Preferably with IVD industry experience

Knowledge, Skills, Abilities

• Scientific knowledge and experience of working with healthcare products
• Regulatory Affairs and / or Quality assurance background
• Good communicator, fast learner
• Proven track record of working to deadlines
• Works well in a team environment
• Eager to learn, develop and progress in RA
• Preferably with IVD experience in manufacturing, development, QA or RA

Physical Requirements / Work Environment

• The role is full time fixed term parental leave cover for up to 18 months
• Ideally, it is an office-based hybrid role (3 days on site and 2 days from home). Remote working may be considered with a regular on-site presence in line with activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.