The Role of Regulatory Affairs in Medical Devices

Bringing a medical device to market requires more than technical innovation — it demands regulatory precision. From CE marking under EU MDR to FDA 510(k) or PMA processes in the U.S., device classification, documentation, risk assessments, and ongoing surveillance are all part of the RA function.

Senior regulatory professionals ensure that a company’s devices meet relevant requirements across their entire lifecycle. But they also shape regulatory strategy — aligning compliance with business goals and guiding teams through increasingly complex regulatory environments.

With the introduction of stricter regulations like EU MDR and IVDR, the expectations placed on regulatory leaders have risen significantly. It’s no longer about navigating approvals — it’s about leading the organisation through regulatory complexity with confidence and foresight.

What a Senior Regulatory Affairs Career Looks Like

In the medical devices space, senior-level RA professionals are heavily involved in both strategic and operational decisions. The focus extends beyond product filings to include market access planning, team leadership, post-market compliance, and business alignment.

Typical responsibilities may include:

• Developing and executing global regulatory strategies for device portfolios

• Leading submission processes for CE marking (EU MDR/IVDR), FDA 510(k)/PMA, and other regional requirements

• Engaging with Notified Bodies, Competent Authorities, and regulatory agencies globally

• Managing Design Dossiers, Technical Files, and Clinical Evaluation Reports

• Overseeing regulatory support for design control, quality systems, and risk management

• Leading regulatory audits, inspections, and readiness reviews

• Building and managing high-performing RA teams across regions

• Advising cross-functional teams on compliance, timelines, and risk mitigation

Common Senior Regulatory Roles in Medical Devices

Titles and scopes can vary, especially depending on whether the company operates globally, in diagnostics, implants, software as a medical device (SaMD), or combination products. Some of the most common leadership roles include:

• Director of Regulatory Affairs – Medical Devices

• Head of Regulatory Affairs – EMEA / Global

• VP of Regulatory Affairs

• Global Regulatory Affairs Lead

• Regulatory Affairs Director – EU MDR / IVDR

• Senior Director, Regulatory & Clinical Affairs

• Chief Regulatory Officer (CRO)

In many organisations, these leaders also sit on executive teams or innovation steering committees, due to the critical influence RA has on business and product strategy.

Advancing a Career in Regulatory Affairs: What Sets Senior Candidates Apart

The shift from manager to director or VP-level in RA comes with broader expectations. Beyond technical knowledge, it’s the ability to lead, influence, and make decisions that align compliance with commercial impact.

1. Deep Understanding of International Regulations

Experience with EU MDR/IVDR, FDA regulations, TGA, and Health Canada requirements is highly sought-after. Professionals who’ve worked through transitions like MDR implementation bring invaluable insight.

2. Lifecycle Regulatory Strategy

Success at senior levels requires experience across the full device lifecycle — from concept and design input through validation, approval, and post-market monitoring.

3. Health Authority Engagement

Being the lead point of contact with Notified Bodies or the FDA demonstrates confidence, expertise, and the ability to communicate risk and value under pressure.

4. Cross-Functional Influence

Strong RA leaders work across R&D, quality, clinical, operations, and marketing — translating regulations into action and supporting business timelines without compromising on compliance.

5. Team Leadership

Those progressing into senior roles often have experience building and scaling RA teams, implementing systems and processes, and mentoring newer professionals in the field.

Industry Outlook: High Demand, Higher Expectations

The global regulatory landscape for medical devices continues to evolve — particularly in the wake of MDR, IVDR, and increased scrutiny on post-market surveillance, clinical evidence, and device safety.

At the same time, innovations in digital health, wearables, diagnostics, and AI-powered devices are pushing the boundaries of existing regulations. As a result, there’s growing demand for regulatory professionals who can operate not just compliantly, but creatively and strategically.

Regulatory Affairs is no longer a back-office function — it’s a business-critical pillar of product success.

How LDI Search Supports Regulatory Affairs Leaders

At LDI Search, we partner with medical device companies across the UK and Europe to place Regulatory Affairs professionals in leadership roles that shape their organisation’s future.

We understand the regulatory and commercial challenges of bringing devices to market, and we’re trusted by hiring teams to identify RA leaders who deliver more than compliance — they deliver impact.

Whether you’re looking to advance your career or build a senior team, we can help.

Browse our current roles or get in touch to speak to a specialist consultant.