Medical and Clinical Affairs Director

We are looking for a Medical & Clinical Affairs Director to shape Flen Health’s global medical and clinical strategy, operations, and cross-functional market success. This is a permanent full-time position based in our office in Belgium-Kontich and reporting directly to CEO. As Medical & Clinical Affairs Director, you will be responsible for defining the evidence roadmap to support MDR lifecycle management and regulatory submissions, while ensuring that all medical and clinical initiatives are fully engaged and strategically aligned with the commercial strategy to maximize market impact and business growth.This position would suit you perfectly if you are driven by a desire to improve patients’ health and have the desire to make things happen.

Your Responsibilities

1. Medical & Clinical Strategy Execution Define, champion, and lead the comprehensive medical and clinical evidence strategy across the entire Flen Health’s portfolio, with a sharp focus on Flaminal pipeline products and next-generation innovations. Develop integrated evidence roadmaps that seamlessly align clinical trial data, regulatory compliance requirements, reimbursement frameworks, and commercial growth objectives. Translate unmet clinical needs and scientific opportunities into commercially viable evidence-generation priorities and robust product differentiation strategies. Ensure all evidence-generation programs are fit-for-purpose, pragmatic, economically viable, and scientifically irreproachable.
2. Clinical Operations & Regulatory Support Provide senior clinical leadership and technical scientific expertise across the global organization. Define and oversee all clinical investigations, Post-Market Clinical Follow-up (PMCF) activities, Real-World Evidence (RWE) generation, and broader clinical programs. Actively support the Regulatory Affairs team, serving as the primary authority on clinical relevance, study design, endpoints, and data requirements needed for Medical Device Regulation (MDR) certifications and global regulatory submissions. Directly line-manage and mentor the Clinical Project Managers, ensuring timely and compliant execution of all trial protocols.
3. Medical Affairs & Commercial Alignment Directly line-manage and provide strategic direction to the Medical Affairs function, driving the scientific engagement strategy, advisory board priorities, and medical education direction. Ensure all Medical Affairs activities directly support commercial strategy, transforming complex clinical data into impactful product positioning, marketing support, and commercial growth. Cultivate high-level relationships with global Key Opinion Leaders (KOLs), scientific experts, and medical societies to elevate Science A’s market presence. Act as the senior medical partner for high-stakes external stakeholder engagements and strategic commercial partnerships.
4. Cross-Functional Leadership Serve as the critical bridge between Regulatory Affairs, Quality Assurance, R&D, Market Access, and Commercial teams to guarantee 100% alignment on product strategy. Partner with Market Access to ensure clinical evidence plans robustly support global reimbursement, Health Economics and Outcomes Research (HEOR), and Health Technology Assessment (HTA) requirements.

Qualifications & Experience

• Advanced scientific or clinical degree (MD, PharmD, PhD, or equivalent) is required.
• 10+ years of progressive experience in Clinical Affairs, Medical Affairs, Clinical Development, or Medical Strategy within the medical device or healthcare industry.
• Experience in skin care, wound care, or closely adjacent therapeutic areas.
• Deep, proven expertise in clinical evidence generation, PMCF design, and stringent MDR clinical compliance requirements.
• Demonstrated track record of translating clinical evidence into commercially successful product positioning and measurable business impact.
• Extensive experience engaging with top-tier KOLs, medical societies, and regulatory bodies.
• Proven leadership capability in a complex, cross-functional, and international matrix environment.
• Direct experience supporting regulatory submissions and navigating complex international medical device approval processes.
• Strong commercial acumen, with a history of aligning medical/clinical milestones with business development and sales objectives.
• Experience supporting reimbursement, HEOR, or market access evidence needs.
• Previous executive leadership or Leadership Team experience.
• Experience in an entrepreneurial or small or medium-sized enterprise (SME) environment where both high-level strategic vision and hands-on execution are required.