Regulatory Affairs Specialist Ii

3 weeks ago


Birmingham, United Kingdom Thermo Fisher Scientific Full time

**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.**:
**Protein Diagnostic Birmingham ( Hybrid 3 days onsite & 2 days remote)**:
Discover Impactful Work:
**To work as part of new product development regulatory affairs team for in vitro diagnostics product range for sale in European and North American markets**:
**Execute necessary submissions and liaise with Health Authorities or Notified Bodies as needed**:
**Represent Regulatory Affairs in development Core Teams**:
**Support compliance activities for QMS to meet regulatory requirements including MDSAP as well as internal audits**:
**Education**:

- Essential B.Sc. in Life sciences
- Desirable M.Sc or higher in life sciences

**Experience**:

- ** 2-5 years in design and development of in vitro diagnostic medical devices**:

- ** 2-5 years working in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent experience of working teams in a regulated industry**:

- ** 2- 5 years in QA/RA roles in healthcare industry (pharma, medical devices or diagnostics)**:
**Knowledge, Skills, Abilities**:

- ** Scientific knowledge and experience or working with healthcare products**:

- ** Fast learner**:
**Good communicator**:
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 with 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.

**Accessibility/Disability Access**:



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