Regulatory Affairs Manager
Created by host on 6/11/2021 10:14:31 AM
Job Title: Regulatory Affairs Manager
Reports to: CTO
Start Date: July 2021
Hours of Work: 37.5 hours per week (full-time, 6-month probation)
Salary: £50-60k PA
Please send your CV and a cover letter explaining what you can bring to MediSieve to firstname.lastname@example.org.
Imagine a world where doctors are able to target and remove infected cells, pathogens, toxins, or even viruses directly from a patient’s bloodstream. At MediSieve we are working towards bringing this dream into a reality. Our Magnetic Blood Filtration System is a device-therapeutic combination that filters harmful substances from the bloodstream using magnetic forces.
If you’ve always dreamt of making a global impact, MediSieve is the place to be! The platform nature of our technology enables us to make a difference in treating humanity's most serious diseases, with the first product targeting hyperinflammation in conditions such as COVID-19, Sepsis, and Cytokine Release Syndrome. And you have the opportunity to join our diverse, energetic, and fun team at the most exciting time – just before our clinical trials begin!
As Regulatory Affairs Manager, you will be responsible for drafting the company’s regulatory documentation, as well as managing our Technical Files and DHFs. You will work directly with our technical team and highly experienced Contractors to help bring each product through the medical device regulatory pathway. This is an opportunity to make a real difference and work on new and exciting projects from an early stage.
What You’ll Be Responsible for
- Development and documentation of pre-market regulatory strategies
- Preparation of regulatory documentation/submissions including, clinical investigation applications, pre-submission applications, and pre-market submissions.
- Ensure company compliance with regulations and standard operating procedures.
- Management of regulatory agency inspections.
- Management of Technical Documentation/File and Device History Files (DHFs).
- Management of post-market compliance including, preparation of regulatory agency reports and correspondence, post-market surveillance reporting and management of product recalls.
- Regulatory intelligence and communication of the output with the team.
- Review of product labelling to ensure claims are compatible with the intended use.
What We Look for in a Candidate
- BSc/MSc in Life Sciences or relevant degree
- Excellent knowledge of EU and US (?) Medical Device Regulations
- At least 5 years of relevant experience in industry
- Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
- Good knowledge of relevant ISO standards (e.g. 13485, 10993, 14971…).
- Experience writing regulatory documentation, including strategies, risk assessments and device classification rationales.
- Experience with compiling design history files and technical documentation/files.
- Experience with managing transport, shelf-life and sterilisation studies in conjunction with a technical team
- Good knowledge of packaging and labelling requirements.
- Experience with post-market activities and regulatory intelligence
- Multiple jurisdiction registrations
- Ability to work independently to manage and prioritise workload, and also work collaboratively as part of a team.
Not Essential, but Helpful
- Excellent knowledge of US Medical Device Regulations
- Knowledge of US FDA regulatory pathways (510(k) and PMA processes)
- Assistance in compiling documentation for clinical investigations
- Correspondence with MHRA and Regulatory Agencies
- Writing strong rationale documents
- Knowledge of devices/therapies using antibodies
- Management of biological and toxicological evaluations
You’ll Love This Job if You Are:
- Meticulous (attention to detail)
- Excellent written communication
- Enthusiastic about our mission
- Remote work
- 3% Company pension
- 25 days holiday
- Share options scheme
- A vibrant community of Imperial College’s Translation & Innovation Hub
Diversity Commitment: We believe that diversity enables us to see situations from different points of view, leading to ideas and insights which would otherwise be missed. We are focused on building an inclusive team of people of all backgrounds, experiences, abilities, and perspectives. We are diverse in gender (58% women), origin (6 nationalities), and economic background. Everyone is welcome — there will be no judgement towards things that make you You!