Regulatory Affairs Manager

Harris Lord Recruitment; Thatcham; Hybrid; GBP 63,000 - 77,000; Full time

Benefits offered by this job

34 days holiday incl. bank holidays

Hybrid working arrangement

Exposure to international regulatory

High visibility within leadership

Influence regulatory strategy

Career progression

Job summary

Harris Lord Recruitment is partnering with an established medical device business to find a Regulatory Affairs Manager who will lead the function and stay actively involved in the technical work. You will steer MDR submissions, manage the regulatory team and collaborate across engineering, marketing and operations to ensure compliant product introductions and lifecycle management.

The role requires a strong regulatory background in medical devices, experience with EU MDR, technical writing

Qualifications

• Strong medical device regulatory background.
• Experience working with EU MDR.
• Technical file and submission experience.
• Exposure to Notified Bodies and regulatory audits.
• Clinical evaluation knowledge.
• Strong technical writing skills.
• Experience supporting regulatory activities across multiple markets.
• Previous people management, mentoring or team leadership experience.
• The confidence to work across departments and influence stakeholders.

Responsibilities

• Lead Regulatory Affairs function whilst remaining hands-on with day-to-day technical work.
• Lead and develop a small Regulatory Affairs team.
• Act as subject matter expert for regulatory affairs across the business.
• Manage MDR submissions and technical file activities.
• Support new product introductions and product changes.
• Lead global market registrations and regulatory submissions.
• Act as PRRC where applicable.
• Support internal and external audits.
• Review and approve regulatory, technical and clinical documentation.
• Provide regulatory input to cross-functional teams including engineering, marketing and operations.
• Support post-market surveillance and clinical evaluation activities.
• Drive continuous improvement across regulatory processes and documentation standards.

Skills

Medical device regulatory

EU MDR experience

Technical writing

People leadership

Cross-functional collaboration

Job description

Regulatory Affairs Manager | Buckinghamshire | c£70,000 + Bonus

Lead a team. Stay hands-on. Help bring innovative medical devices to market across the globe.

Some Regulatory Affairs roles are all governance, meetings and delegation.

This isn't one of them.

This is a role for someone who still enjoys the technical side of regulatory affairs, but also wants the opportunity to lead, develop people and influence the direction of a growing medical device business.

You’ll be joining an established and innovative manufacturer with an international footprint, a healthy pipeline of new products and a reputation for developing practical, clinician-led solutions that genuinely improve patient care.

The regulatory team is already in place. What they need now is a leader who can bring structure, clarity, technical expertise and support. Someone who enjoys rolling their sleeves up, making decisions, developing capability and helping the wider business navigate increasingly complex global regulatory requirements.

If you're looking for a role where you'll be visible, valued and genuinely able to make an impact, read on.

What You'll Be Doing

You will lead the Regulatory Affairs function whilst remaining actively involved in the day-to-day technical work. This isn't a management-by-spreadsheet role. You'll be working alongside the team, supporting projects, making decisions and helping drive regulatory activity across a diverse medical device portfolio.

• Leading and developing a small Regulatory Affairs team
• Acting as the business's subject matter expert for regulatory affairs
• Managing MDR submissions and technical file activities
• Supporting new product introductions and product changes
• Leading global market registrations and regulatory submissions
• Acting as Person Responsible for Regulatory Compliance (PRRC)
• Supporting internal and external audits
• Reviewing and approving regulatory, technical and clinical documentation
• Providing regulatory input to cross-functional teams including engineering, marketing and operations
• Supporting post-market surveillance and clinical evaluation activities
• Driving continuous improvement across regulatory processes and documentation standards

What They're Looking For

This role needs someone who combines technical credibility with leadership capability. You don't necessarily need twenty years of management experience. What matters more is your ability to lead people, make good decisions, coach others and provide confidence and direction when it matters.

You’ll probably bring:

• A strong medical device regulatory background
• Experience working with EU MDR
• Technical file and submission experience
• Exposure to Notified Bodies and regulatory audits
• Clinical evaluation knowledge
• Strong technical writing skills
• Experience supporting regulatory activities across multiple markets
• Previous people management, mentoring or team leadership experience
• The confidence to work across departments and influence stakeholders

What You Won't Find Here

• Layers of corporate bureaucracy
• A role where you're managing from a distance
• Endless meetings with no accountability
• A team of twenty people writing documents on your behalf

Instead, you'll be working in a successful SME environment where people are expected to contribute, collaborate and get things done. Decisions happen quickly, people know each other and good ideas are welcomed wherever they come from.

About The Company

Our client is an established and highly respected medical device manufacturer with a long history of innovation and international growth. Developing products across the surgical sector, the business works closely with healthcare professionals to design and manufacture devices that improve patient care and clinical outcomes. Its products are used internationally and the organisation continues to invest heavily in product development, regulatory excellence and future growth.

Despite its international reach, it retains the culture and agility of a successful SME. People have visibility. Contributions matter. Decisions get made.

Package

Salary: c£70,000 + Bonus

Benefits:

• 34 days holiday including bank holidays and Christmas closure
• Hybrid working arrangement
• Exposure to international regulatory activities
• High visibility within the leadership team
• Opportunity to influence business growth and regulatory strategy
• Career progression within a successful and growing medical device business