RA / Regulatory Affairs Specialist, IVD Medical Devices
Location: Manchester, 3 days office 2 working from home/ remote.
Hours: Monday to Friday 9:00am - 5:00pm
Salary: Competitive, reflective of an RA Specialist typically with 2 years CIRCA experience
Additional: Parking onsite, 3/5% pension contribution, Life Assurance, Private Medical
Additional: Share incentive scheme, online learning toolkit, 25 days AL + BH and Birthdays etc
Our Client, an IVD - Medical Devices company and a leader on the COVID PCR manufacturing side is looking to add to their existing RA team and recruit for an RA Specialist who will progress within the ranks there.
Senior RA Specialist/RA Manager
This role will help support the RA team according to the organisation's regulatory affairs strategy, in order to fulfil the company's global commercial strategy. The role requires understanding of the current IVD regulatory framework and processes, in order to progress documentation, to primarily support regional submissions and maintenance of CE-IVD/Regional dossiers.
Key areas of responsibility:
- The maintenance of Technical Documentation Files for the YGH device range in accordance with the requirements of the IVDD 98/79/EC and IVDR (EU) 2017/746 for CE-marking activities.
- Administrate regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.
- Maintain specialist knowledge and tracking of the regulatory requirements within each of operational geographical territories.
- Support for the development of the companies regulatory planning, incorporating strategies for the product range in accordance with global requirements.
- Support product risk management activities and the life-cycle of marketed products.
- Support for the post market surveillance, preparing reports for the product range according to YGH procedures.
- Support the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post market activities.
- Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements as identified.
- Degree in a life science or equivalent either in genetics or molecular biology and significant experience working within a regulatory affairs arena.
- Knowledge of ISO 13485 and IVD RA requirements is ESSENTIAL
- Awareness of the IVD Regulations.
- Excellent organisational skills and an ability to work to tight timelines.
- Demonstrate strong team skills.
- Proficient in the use of IT, including Microsoft Office suite and Electronic Document Management systems.
- Excellent communication skills when liaising within the company and with external customers.