Regulatory Strategy & Operations Leader

Standout; United Kingdom; Hybrid; GBP 81,000 - 99,000; Full time

Benefits offered by this job

Bonus

Car allowance

Pension

Flexible benefits

Job summary

Medical Device & IVD Consultancy in the UK seeks a Head of Regulatory Consulting & Operations to lead the regulatory consulting function. You will mentor a senior team, own client relationships, scope new projects, and craft practical regulatory strategies for CE/UKCA MDR/IVDR across the UK, EU, and US.

You will shape processes, ensure high-quality deliverables, and represent the firm at conferences and events, driving growth while maintaining a hands-on leadership style.

Qualifications

• 10+ years in medical device and/or IVD regulatory affairs.
• Experience compiling/reviewing CE and UKCA dossiers under MDR/IVDR and UK MDR.
• Knowledge of ISO 13485 and FDA QMSR (21 CFR Part 820).
• Proven leadership in consultancy or multi-client environments.
• Commercially minded with ability to scope and quote.
• US regulatory experience is a plus.
• Regulatory depth across devices/IVDs.
• Strong client-facing communication and attention to detail.

Responsibilities

• Lead and mentor the senior consulting team and maintain quality across outputs.
• Own client relationships as the main point of contact.
• Scope new projects, prepare quotes, and develop regulatory strategies.
• Review client deliverables including technical docs, QMS, and regulatory submissions.
• Lead next-step and feedback calls and manage feedback/complaints.
• Improve internal processes and governance.
• Represent the business at events and identify opportunities.

Skills

Leadership

Client management

Regulatory strategy

Project scoping

Regulatory submissions

QMS knowledge

MDR/IVDR

ISO 13485

Regulatory affairs

Travel flexibility

Education

Science/Engineering/Clinical degree

Job description

Medical Device & IVD Consultancy in the UK seeks a Head of Regulatory Consulting & Operations to lead the regulatory consulting function. You will mentor a senior team, own client relationships, scope new projects, and craft practical regulatory strategies for CE/UKCA MDR/IVDR across the UK, EU, and US.

You will shape processes, ensure high-quality deliverables, and represent the firm at conferences and events, driving growth while maintaining a hands-on leadership style.