At a Glance
- Tasks: Coordinate global regulatory submissions and support cross-functional projects in the medical device sector.
- Company: Join a dynamic team focused on innovative medical technologies.
- Benefits: Competitive salary, bonus, 25 days holiday, and private medical insurance.
- Other info: Collaborative environment with excellent career growth opportunities.
- Why this job: Make a real impact on patient access to cutting-edge medical devices.
- Qualifications: Degree in a scientific field and experience in regulatory affairs or quality.
The predicted salary is between 63000 - 77000 £ per year.
Location: Cirencester
Job Type: Full-time Hybrid after completion of probation
Department: Regulatory Affairs
We are seeking a highly organised and proactive Regulatory Operations Project Coordinator to support global regulatory submissions and Regulatory Affairs projects across our medical device portfolio. In this role, you will coordinate regulatory activities from planning through to completion, ensuring clear ownership, timelines, and deliverables are established and maintained. Working closely with Regulatory Affairs and cross-functional teams including Clinical, Quality, R&D, Product Management, Manufacturing, and Supply Chain, you will play a key role in driving regulatory projects forward and supporting continuous improvement within Regulatory Affairs operations.
This is an excellent opportunity for someone with regulatory, quality, or medical device industry experience who enjoys coordinating complex activities, collaborating across teams, and ensuring critical regulatory milestones are delivered successfully.
As Regulatory Operations Project Coordinator, you will:
- Coordinate global regulatory submissions, registration projects, product lifecycle activities, and regulatory change initiatives, developing clear project plans and identifying dependencies.
- Track regulatory deliverables, submissions, approvals, and competent authority queries, escalating risks, issues, or delays where appropriate.
- Coordinate inputs and documentation from Regulatory Affairs and cross-functional stakeholders to support submissions and regulatory projects.
- Maintain visibility of regulatory projects globally, supporting prioritisation, resource planning, and progress reporting.
- Coordinate regulatory transition activities, including MDR transition programmes and implementation activities following regulatory approvals or certifications.
- Support regulatory impact assessments associated with product, manufacturing, supplier, and labelling changes, ensuring resulting actions are tracked through to completion.
- Contribute to the development and continuous improvement of Regulatory Affairs systems, processes, and ways of working.
- Support the implementation and enhancement of Regulatory Information Management Systems (RIMS) and other Regulatory Affairs tools.
- Assist with internal and external audits and support the maintenance of regulatory procedures and documentation.
- Ensure compliance with Quality Management System requirements and applicable regulations, including ISO 13485, EU MDR 2017/745, and FDA requirements.
About You
Essential
- Degree qualification, preferably in a scientific, engineering, or related discipline.
- Experience within Regulatory Affairs, Quality, or another regulated medical device environment.
- Understanding of medical device regulatory submissions, registrations, and product lifecycle management activities.
- Strong project coordination and organisational skills, with the ability to manage multiple activities simultaneously.
- Excellent attention to detail and a structured approach to work.
- Strong interpersonal and communication skills, with the confidence to work effectively across functions and levels of the organisation.
- Proven ability to drive actions to completion and manage competing priorities.
- Strong problem-solving and stakeholder management skills.
Desirable
- Experience supporting global regulatory submissions or registration projects.
- Knowledge of Regulatory Information Management Systems (RIMS).
- Familiarity with EU MDR, ISO 13485, FDA regulations, and other international regulatory requirements.
Why Join Us?
- Opportunity to work on global regulatory projects that directly impact patient access to innovative medical technologies.
- A competitive salary Circa £30,000 with a discretionary annual bonus.
- 25 days holiday plus bank holidays.
- Excellent pension – starts at 6%, going up to 9.7% after 18 months.
- Life assurance – Six times your basic salary.
- Private medical insurance with BUPA for you and your family.
- Free annual eye tests and flu vaccinations.
- Employee referral program where you can earn from £1,000 for each successful hire you recommend.
- Collaborative and supportive cross-functional environment.
- Exposure to international regulatory submissions and compliance activities.
- Opportunity to influence and improve regulatory systems, processes, and ways of working.
- Professional development and career growth within Regulatory Affairs and Operations.
If you are an organised project coordinator with experience in regulated environments and a passion for driving projects to successful completion, we would love to hear from you. Apply today.
Regulatory Operations Project Coordinator employer: Corin
Corin is an exceptional employer that fosters a collaborative and innovative work culture, particularly for those in the Senior Software Quality Engineer role. With a strong commitment to employee growth, you will benefit from a hybrid working environment, generous holiday allowance, and comprehensive health benefits, all while contributing to groundbreaking technologies that enhance patient outcomes globally.
