Regulatory Affairs Assistant (IVD)

Stirling Q&R; Reading; On-site; GBP 30,000 - 35,000; Full time

Job summary

Stirling Q&R in Reading is seeking a Regulatory Affairs Assistant to support an IVDR transformation project across the regulatory team. You will handle day-to-day regulatory queries and gather information for managers, enabling submissions without writing them yourself.

The role is a 12-month fixed-term contract, full-time and on-site in Reading. Start as soon as possible, ideally before Christmas, with a salary of £30,000–£35,000 per year.

Qualifications

• Ideally 1–2 years in regulatory affairs, quality or a related role in IVD, medical devices or life sciences.
• An interest in regulatory affairs and IVDR.
• Strong organisation, accuracy and written communication.
• A science degree or similar is helpful.

Responsibilities

• Answer customer facing regulatory queries accurately and on time
• Support the day to day running of the Regulatory Affairs function
• Gather, organise and prepare documents so the Regulatory Managers can compile technical files and submissions
• Support the IVDR transformation project with tracking, records and admin
• Work closely with Quality and other teams on site

Skills

Regulatory knowledge

Attention to detail

Written communication

Education

Science degree or related field

Job description

Our client is an established international diagnostics and life science products business with a site in Reading. Their Regulatory Affairs team is delivering a 12 month IVDR transformation project, and they need a Regulatory Affairs Assistant to support the team through it.

This is a great first or second step in regulatory affairs. You will take on day to day regulatory tasks and customer regulatory queries, so the Regulatory Managers can focus on submissions. You will not write technical files or submissions yourself; you will gather, organise and prepare the information the managers need to do so.

What you will do:

• Answer customer facing regulatory queries accurately and on time
• Support the day to day running of the Regulatory Affairs function
• Gather, organise and prepare documents so the Regulatory Managers can compile technical files and submissions
• Support the IVDR transformation project with tracking, records and admin
• Work closely with Quality and other teams on site

12 month fixed term contract, full time, fully on site in Reading, Berkshire. Salary £30,000 to £35,000 per year. Start as soon as possible, ideally before Christmas.

Stirling Q&R is a specialist Quality and Regulatory recruitment firm, acting as an employment agency for this vacancy.

Ideally 1 to 2 years in regulatory affairs, quality or a related role in IVD, medical devices or life sciencesAn interest in regulatory affairs and IVDRStrong organisation, accuracy and written communicationA science degree or similar is helpful