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Regulatory Affairs Specialist

Job LocationEdgbaston
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

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.Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovationWe now have a fantastic opportunity in our growing Regulatory Affairs department working as a Regulatory Affairs Specialist. You will work as part of global regulatory affairs team for invitro diagnostics product range for sale in global markets - including EMEA, USA, LATAM, AsiaPac. This role will require for you to significantly interaction with all departments and external regulatory authorities, involvement in company projects and developments. We are looking for an individual who is eager to learn and has an ambition to develop further in the career.This role will include

  • Regulatory review and inputs for controlled documents
  • Assist in compilation of global regulatory affairs submissions including STED CE file, FDA
  • Assist in all regulatory affairs activities contributing to overall company objectives
  • Support internal audits and 3rd party audits
  • Support compliance activities for QMS to meet regulatory requirements including MDSAP
  • Multi-department and multi-level interactions
  • You have
  • Sc. in Life sciences
  • 2- 5 years in QA/RA roles in healthcare industry (pharma, medical devices or diagnostics)
  • 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
  • Scientific knowledge and experience or working with healthcare products
  • Regulatory Affairs and / or Quality assurance background
  • Ability to work with teams and gain consensus
  • Ability to assess options to support decision making process
  • Why choose a career with us 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, collaborationand 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.Our values provide a definite direction for everything we do, and we are always in search for talents who wants to be part of our journey. Are you dedicated and want to make a difference Are you enthusiastic and have passion in what we do Do you hold integrity close to your heart Then we would be delighted to talk to you.

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