Head of Regulatory Affairs

JR United Kingdom; City of Edinburgh; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading global diagnostics innovator is seeking a Regulatory Affairs Division Leader to guide their expansion into the US market. This role involves overseeing global regulatory strategy, ensuring compliance, and leading a team in a dynamic environment. The position offers state-of-the-art facilities and opportunities for international progression within a collaborative culture.

Benefits

State-of-the-art facilities

Collaborative, people-first culture

Opportunities for international secondments

Qualifications

• Experience in diagnostics or medical device manufacturing.
• Strong track record with FDA, CE marking, IVDR, and ISO13485.

Responsibilities

• Lead the regulatory function across global markets.
• Oversee regulatory submissions: CE marking, FDA, Health Canada.
• Ensure company-wide compliance and audit readiness.

Skills

Leadership

Strategic Influence

Job description

We're Hiring: Regulatory Affairs Division Leader – Diagnostics | Edinburgh (Hybrid)

A global diagnostics innovator is entering a major growth phase, and we’re searching for a proven Regulatory Affairs Leader to steer them through it.

Backed by significant investment and driving into the US market with FDA submissions, this company is scaling up fast, launching new products, expanding manufacturing, and assembling a US commercial team.

Your Mission:

Lead the regulatory function across global markets, oversee compliance, and drive strategy. You’ll be the go-to expert guiding the business through complex regulatory landscapes, from ISO13485 to FDA and IVDR.

What You’ll Be Doing:

• Owning global RA strategy and leading from the front
• Overseeing regulatory submissions: CE marking (IVDD/IVDR), FDA, Health Canada
• Ensuring company-wide compliance and audit readiness
• Leading your team and partnering with senior cross-functional stakeholders
• Contributing to quality initiatives and post-market surveillance
• Navigating evolving international legislation and regulatory requirements

What You’ll Bring:

Experience in diagnostics or medical device manufacturing

Strong track record with FDA, CE marking, IVDR, and ISO13485

Leadership and strategic influence in regulatory functions

A sharp, decisive, and collaborative mindset

Why Join?

State-of-the-art facilities in Edinburgh

Collaborative, people-first culture with regular team incentives

Opportunities for international secondments and long-term progression