Regulatory Affairs Executive

We are a contract development and manufacturing organisation making biologics and sterile injectables for drug companies. We started in 2009 and have grown to about 100 people. Manufacturing runs 24/7 on 12-hour rotating shifts.

KL Biosciences is hiring a Regulatory Affairs Executive to support 510(k) and De Novo submissions for our cardiovascular device portfolio. On site, Manchester.

What you'll do:

• Maintain establishment registrations and device listings
• Keep regulatory files and correspondence organised and inspection ready
• Build regulatory strategy memos for new products and line extensions
• Support EU MDR technical documentation and notified body reviews
• Monitor new guidance documents and summarise changes for the business
• Assess design and manufacturing changes for regulatory impact and document the rationale
• Track submission timelines and commitments in Veeva Vault RIM or a similar system
• Coordinate with international distributors on country registrations

What you'll need:

• 2+ years of regulatory affairs experience in medical devices, pharma or biologics
• Familiarity with eCTD structure and submission publishing tools
• Able to travel up to 10 percent
• Clear technical writing and careful editing

Preferred:

• RAC certification from RAPS
• EU MDR or IVDR transition experience
• Software as a medical device (SaMD) and cybersecurity submissions

Benefits:

Pay: £47,000 - £57,000 per annum

• Workplace pension
• 25 days holiday plus bank holidays
• Cycle to work scheme
• Employee assistance programme

Interviews will be held in person at our Manchester office.

No agencies please.

Start: Flexible.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at KL Biosciences Ltd.