Director, IVD Regulatory Consulting

Job description

Accountabilities: This role is responsible for leading regulatory consulting engagements and shaping global strategies for in vitro diagnostic (IVD) products while ensuring compliance, quality, and market access success. Lead the development and execution of global regulatory strategies for IVD products, including submissions, approvals, and post-market requirements. Direct preparation, review, and submission of regulatory documentation and technical reports, ensuring alignment with global regulatory standards. Provide strategic guidance on analytical and clinical study design to support regulatory filings and agency responses. Collaborate with internal teams, external experts, and scientific leaders to strengthen regulatory and development strategies. Support business development activities including proposal development, bid defense presentations, and client advisory discussions. Translate client needs into actionable regulatory strategies and support go-to-market planning and commercialization efforts. Oversee internal quality, documentation standards, and project governance for consulting engagements. Requirements This role requires deep expertise in regulatory affairs, strong leadership capabilities, and a proven track record in diagnostics, life sciences, or consulting environments. Bachelor’s degree in Life Sciences or related field (Master’s preferred). 7+ years of industry experience in medical devices, pharmaceuticals, clinical trials, or regulatory consulting. At least 5+ years of direct regulatory affairs consulting experience, ideally focused on diagnostics or IVDs. Strong understanding of global regulatory frameworks, quality systems, and marketing authorization processes. Demonstrated ability to develop and execute global regulatory strategies for complex products. Strong leadership, communication, and stakeholder management skills. Business acumen with the ability to support client development and commercial growth initiatives. Analytical mindset with strong problem-solving skills and the ability to navigate complex regulatory challenges. Experience managing teams and cross-functional project delivery. Benefits Competitive compensation package with an estimated annual salary range of $162,000 – $243,000 USD. Eligibility for annual discretionary bonus and performance-based incentives. Comprehensive benefits including medical, dental, vision, life, and disability insurance. Retirement savings plans and financial wellbeing support. Paid time off, parental leave, and sick leave benefits. Professional development support, including training and career growth opportunities. Exposure to high-impact global projects across leading life sciences and diagnostics organizations. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, IVD Regulatory Consulting in the United States. This senior-level consulting role sits at the intersection of regulatory strategy, diagnostics innovation, and global market access. You will act as a trusted advisor to life sciences and diagnostic clients, shaping regulatory pathways for in vitro diagnostics across diverse international markets. The position combines deep scientific and regulatory expertise with strong commercial awareness, enabling you to design strategies that accelerate product approvals and market readiness. You will lead high-impact client engagements while contributing to business growth through thought leadership and strategic advisory services. Working in a highly collaborative consulting environment, you will partner with cross-functional experts, external stakeholders, and internal teams to solve complex regulatory challenges. This role offers the opportunity to influence product development and commercialization strategies across both emerging and established healthcare companies.