Global Head of Quality & Regulatory Affairs

About the Opportunity

An innovative and fast-growing organization operating within the Medical Device, Health & Wellness, and Consumer Healthcare sectors is seeking an experienced Quality & Regulatory Affairs leader to oversee its global QA/RA function.

Reporting directly to the CEO, this role offers the opportunity to shape quality, regulatory strategy, and product compliance across operations in Europe and North America, while supporting the company's next phase of growth, portfolio expansion, and international development.

This is a leadership role, but equally requires a hands-on individual who is comfortable balancing strategic initiatives with operational execution.

The Opportunity

The organization has recently entered a new phase of growth under new executive leadership, with significant investment in product innovation and business expansion. As a result, Quality and Regulatory Affairs have become critical functions in supporting the company's long-term ambitions.

While the position carries global responsibility, the current operational footprint is primarily across Europe and North America, with plans to expand into additional international markets over the coming years.

Key Responsibilities

• Lead and develop the global Quality Management and Regulatory Affairs function, driving both strategic and operational excellence.
• Serve as the primary quality and regulatory advisor to senior leadership and cross-functional stakeholders.
• Maintain ownership of the company's global Quality Management System (QMS), ensuring compliance with international standards and regulations.
• Act as the designated Quality Management Representative and champion a strong culture of quality throughout the organization.
• Lead, develop, and mentor the QA/RA team while maintaining active involvement in day-to-day operational activities.
• Drive continuous improvement initiatives across quality systems, processes, and regulatory compliance activities.
• Plan, manage, and support internal, external, customer, and regulatory audits.
• Oversee global product registrations, regulatory submissions, renewals, and market access activities.
• Partner closely with R&D, Product Management, Medical Affairs, Operations, Manufacturing, and Commercial teams to support product development and commercialization.
• Support the introduction of new products and technologies through effective quality and regulatory leadership.
• Monitor evolving regulatory requirements and implement necessary changes to ensure ongoing compliance across all relevant markets.

Candidate Profile

Essential Experience

• Degree in Life Sciences, Engineering, Pharmacy, Medicine, Regulatory Affairs, Quality Management, or a related field.
• Extensive experience within both Quality Management and Regulatory Affairs in a regulated Medical Device environment.
• Demonstrated ability to operate across both disciplines, with a balanced QA and RA background rather than a specialization in only one area.
• Strong knowledge of ISO 13485, ISO 9001, MDR, MDSAP, FDA 21 CFR Part 820, and other relevant global regulations.
• Proven experience managing audits, inspections, quality systems, and regulatory submissions.
• Experience supporting new product development, product launches, and portfolio expansion initiatives.
• Track record of working within growth-oriented organizations undergoing transformation or expansion.
• Strong understanding of international market access and regulatory compliance requirements.

Leadership & Personal Attributes

• Hands-on leader who remains close to operational execution.
• Able to balance strategic thinking with practical implementation.
• Comfortable working across multiple business functions and stakeholder groups.
• Strong decision-maker with a pragmatic and solutions-focused mindset.
• Experienced in building, developing, and leading high-performing teams.
• Adaptable and comfortable operating within a growing and evolving business environment.
• Strong communicator capable of translating complex quality and regulatory requirements into practical business actions.
• Entrepreneurial mindset with the ability to build processes, improve systems, and drive change.

This opportunity would suit a senior Quality & Regulatory Affairs professional who combines strong leadership skills with a genuinely hands-on approach and is excited by the challenge of helping a growing organization scale its quality and regulatory capabilities while supporting ambitious product and market expansion plans.