Regulatory Affairs Specialist

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

Do you want to make a difference?

If the answer is ‘yes’ then you’re just the kind of person we’re looking for!

We are looking for a Regulatory Affairs Specialist who is organised, committed, methodical, passionate individual to work in our busy Regulatory affairs department.

The Regulatory Affairs Specialist is responsible for assisting in all global regulatory affairs activities to contribute to overall company objectives.

The role is for UK based candidates, remote working /hybrid and will require regular travel to the UK Head office based in Birmingham.

Responsibilities include: -
• Assisting regulatory affairs projects for in vitro diagnostics to meet requirements of global markets, including EU, USA, Asia Pacific & LATAM
• Vigilance activities which include:
• contributing to the vigilance... decision process
• writing of vigilance notices
• communications with national competent authorities.
• Assist in post market surveillance activities
• Support regulatory compliance activities for products and QMS requirements, including MDSAP and IVDR
• Regulatory review of controlled documents
• Support key development projects to meet strategic business objectives
• Assist in global submissions including EU, FDA
• Support internal audits
• Support 3rd party audits

Experience required: -
• A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent.
• Several years in QA/RA roles in healthcare industry (IVDs, medical devices or similar)
• IVD industry experience
• R&D clinical, production research & development

Rewards & Benefits:

Competitive Salary

Contributory Pension, 6% company contribution

Annual Bonus scheme

25 days annual plus bank holiday and service days

Life cover 3 x salary

Medicash Healthcare Plan, this includes routine dental treatment, opticians, prescription charges,

Sustainable Electric Car Scheme

Cycle to work scheme, up to £2500

Travel wise, travel assistance scheme

Working for us:

Founded in 1986 by a group of former researchers based at the University of Birmingham, Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency. Our position as a scientific leader in our field for Multiple Myeloma provides solutions to clinicians and laboratories around the world.

Integral to the success of Binding Site, is the way we value, develop, and empower our workforce. Everyone is welcome irrespective of race, gender, ethnicity, sexuality, religion, age or disability. We pride ourselves on been an inclusive employer for all, reinforced by been Business Disability Forum Member , Stonewall Champion & LGBQT+ foundation.

There’s lots of opportunities to get involved with our Charity Committee, EDI or Employee forums in creating a collaborative culture by winning together and making a difference every day

We recognise that work plays a big part in our lives, so we are proud of our positive employee engagement record, our and our commitment to continue listening to our people and improving what we do. We firmly believe that by working together we can make the Binding Site the best possible place to work and build a sustainable future for our workforce and local communities.

In addition, Binding Site has been recognised at the 2021 Birmingham Post Business Awards, winning both “Company of the Year” and “International Trade and Export” Awards.

We aim to make reasonable adjustments and adaptions to ensure our recruitment process is inclusive to all. Please get in touch directly if there is specific support required
Birmingham UK

Salary Criteria