Science Regulatory Affairs Manager - Regulatory Affairs Jobs
Applications Support, Product Specialist, Training

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Covering the following locations: Birmingham, Derby, Leicester, Nottingham, Oxford, Reading, Sheffield, Swindon

Here at the Binding Site, we have all experienced the impact that the pandemic has had both on a personal and professional level, and as an organisation we are committed to fight against Covid-19. Working very closely with the University of Birmingham and pulling together as a close team, we developed a high-quality antibody test in record time.

The Binding Site is built on strong scientific foundations with extensive expertise in antibody specificity technology. We are committed to improve patient lives worldwide through education, collaboration and innovation. Our teams provide clinics and laboratories the tools to significantly improve diagnosis and management of patients across a range of cancers and immune system disorders.

Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?

We have a fantastic opportunity working in our growing Regulatory Affairs department. The successful candidate will be required to:

- Lead, manage and organise a team of Regulatory Affairs professionals for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM.
- Represent the company for 3rd party submissions for FDA, Notified Bodies and global regulatory authorities.
- Support key development projects to meet strategic business objectives.
- Manage global submissions including EU, FDA.
- Represent Regulatory Affairs in product development projects
- Support Internal audits.
- Represent Regulatory Affairs in 3rd party audits - MDSAP, FDA
- Support department in maintaining company compliance to QMS requirements - MDSAP
- Planning activities to support budget and headcount

Person Specification:
B.Sc. in Life sciences (or equivalent)
Management or supervisory in Quality Assurance/Regulatory Affairs, in the healthcare industry (pharma, medical devices or diagnostics)
Management or supervisory in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent.
Excellent communication skills (both written and Verbal
Scientific knowledge and experience or working with healthcare products
Regulatory Affairs and / or Quality assurance background
To be focussed and have the ability to work as part of a team.
To be motivated and have the ability to motivate others
To be friendly and approachable and have a positive attitude
To be flexible to the needs of the business

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Job Ref: 67067

Nick Walker

Scientific Recruiter

nickw@zenopa.com 01494 818 059

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Tags

applications support    product specialist    training    troubleshooting