Regulatory Affairs HealthcareLocation: HullEmployment Type: PermanentCompetitive Salary & Benefits PackageSRG are currently working a global, market-leading Healthcare organisation in the UK who are actively seeking...
Regulatory Affairs/Junior Regulatory Affairs (RA) Officer
15 month fixed term contract (FTC)
SRG are looking for enthusiastic individuals who are looking to make the move into Regulatory Affairs (RA) or already have some experience in this field. This is a fantastic opportunity to join a successful medical device company at an exciting time for the business.
The RA department is responsible for managing product license registration with the appropriate regulatory authorities on a worldwide basis. This includes the preparation of any regulatory dossiers and/or supporting documentation. In addition the department is responsible for liaising with worldwideregulatory bodies to confirm compliance issues and to provide this information to the appropriate staff groups.
- Prepare and maintain internal regulatory documentation.
- Prepare and submit technical documentation for submission to competent authorities.
- Coordinate creation of product labelling in line with applicable requirements.
- Liaise with internal team members, regulatory agencies, external customers/distributors andlabelling suppliers.
- Maintain good working knowledge of regulatory requirements.
- Conduct all duties in compliance with cGMP, ISO 13485, ISO 9001, Good Documentation Practice (GDP) and appropriate regulatory requirements.
- A relevant degree and/or relevant work experience in a regulatory affairs environment is essential
- Ability to prepare coherent regulatory reports and filings
- Excellent level of IT skills and must be confident using IT packages such as MS Office
- Good people skills, ability to liaise with different stakeholders, problem solver, excellent attention todetail and good decision making skills.
This is a fantastic opportunity for someone with RA experience or to gain experience within regulatory affairs (RA) and make the move into this "in demand" area of the scientific industry!
Key words: regulatory, regulatory affairs, RA, GMP, cGMP, GDP, medical device, BLA, Biologics License Applications, PMA, Premarket Approval, FDA
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.