Regulatory Affairs Manager
Oxsed, United Kingdom

We are currently looking for a Regulatory Affairs Manager to provide regulatory expertise within all current and upcoming projects in the company. The successful candidate will combine their knowledge of scientific, regulatory and commercial business issues to enable products that are developed, manufactured or distributed to meet required legislation.

Since spinning out of Oxford University last year, Oxsed has already grown to 80+ people and we expect to continue this growth throughout 2021 and beyond. Oxsed is using pioneering OxLAMP technology to provide rapid, accurate and affordable COVID testing throughout the UK.

Oxsed's HQ is in Oxford, but we already have testing sites at Heathrow, Stansted, Luton, Manchester and the O2 in London as we help support a reopening of travel and events this year.

• Preparation and submission of regulatory applications and registrations of all related activities: post-market surveillance, regulatory review of promotional materials, registrations and submissions to authorities
• Leading / compiling all materials required in submissions and annual registrations
• Key liaison and correspondence to review agencies, notified bodies, and trade associations (e.g. UKAS, MHRA, EMA, etc) on matters relating to product registrations and PMS
• Responsibility for Product Field Safety Corrective Actions (FSCA) in the region, including submission, and their efficient and timely execution, including to plan closure as per Corporate plans
• Ensuring new regulatory requirements are monitored and impact assessed and changes in local procedures to ensure compliance are recommended
• Provide input for product development and planning throughout the product lifecycle
• Work across Regulatory and Quality functions, ensuring timely advice and insight
• Help regulatory affairs in product recall and recall communication process
• Assist in maintaining annual licenses, registrations, listings, patent information and internal auditing.

Requirements

• 3 to 5 years’ regulatory affairs experience, including knowledge of reporting and vigilance requirements in different territories
• Experience in at least one of the following areas:
  • CE Marking
  • UKAS (ISO 15189, ISO 13485, ISO 22870)
  • MHRA/EMA/FDA/CFDA Compliance
  • Unique Device Identification (UDI)
  • EU Medical Device Regulation (MDR) Compliance
  • In Vitro Diagnostic Regulation (IVDR) Compliance
  • Clinical Evaluations Reporting (CER)
• Detail-oriented and excellent written and verbal communication skills
• Ability to work independently
• Ability to plan and manage workload
• Strong interpersonal skills and the ability to work as part of a team
• Ability to support employees from other teams

Job Rewards and Benefits