Regulatory Affairs Specialist Ii - Birmingham, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Birmingham, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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

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 officebased hybrid role (3 days on site and 2 days from home). Remote working may be considered with a regular onsite 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.