Regulatory Operations Project Coordinator

Corin Group; Cirencester; Hybrid; GBP 27,000 - 33,000; Full time

Benefits offered by this job

Discretionary annual bonus

6%-9.7% pension

Life assurance

Private medical insurance (BUPA)

Free annual eye tests

Employee referral programme £1,000

Career development in Regulatory

Job summary

Corin Group is seeking a Regulatory Operations Project Coordinator in Cirencester to support global regulatory submissions and cross-functional Regulatory Affairs projects across our medical device portfolio.

Responsibilities include planning, coordinating inputs, and ensuring on-time delivery of regulatory milestones while collaborating with Clinical, Quality, R&D, Product Management, Manufacturing and Supply Chain teams.

Qualifications

• Degree in a scientific, engineering or related discipline.
• Experience in Regulatory Affairs, Quality, or a regulated medical device environment.
• Understanding of regulatory submissions, registrations, and lifecycle management.

Responsibilities

• Coordinate global regulatory submissions, registrations and lifecycle activities with clear project plans.
• Track deliverables, submissions, approvals and regulatory queries, escalating risks when needed.
• Coordinate inputs from Regulatory Affairs and cross-functional stakeholders for submissions and projects.

Skills

Project coordination

Organisational skills

Attention to detail

Interpersonal communication

Stakeholder management

Regulatory submissions

RIMS knowledge

EU MDR / ISO 13485 / FDA familiarity

Cross-functional collaboration

Problem solving

Education

Science or Engineering degree

Tools

RIMS

Job description

Regulatory Operations Project Coordinator

Job Description

Posted Thursday 20 August 2026 at 00:00

Regulatory Operations Project Coordinator

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

• 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.
• 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
• 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.

IND007

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.