Vice President, Regulatory Affairs

Responsibilities

Regulatory Strategy & Business Leadership

• Develop and execute the global regulatory strategy for the Company's portfolio of medical devices, software-enabled solutions, and future technology platforms.
• Serve as a strategic advisor to executive leadership on regulatory trends, business risks, market access opportunities, and emerging global requirements.
• Partner with Business Unit and functional leaders to support growth initiatives, market expansion, portfolio optimization, and commercialization strategies.
• Ensure regulatory strategy is aligned with corporate objectives, innovation priorities, and long-term business plans.
• Identify and mitigate regulatory risks while enabling speed-to-market and competitive advantage.

Product Development & Innovation

• Provide regulatory leadership throughout the product development lifecycle, from concept through commercialization and lifecycle management.
• Partner with R&D and Product Development leaders to establish innovative regulatory pathways that accelerate product approvals and market access.
• Support breakthrough technologies, next-generation medical devices, women's health innovations, digital health solutions, connected devices, software-enabled products, and emerging technologies.
• Ensure regulatory requirements are effectively integrated into design controls, risk management, verification and validation activities, clinical evaluations, and product launch planning.
• Guide regulatory strategy for significant product changes, line extensions, and technology platform development.

Global Regulatory Submissions & Market Access

• Lead the development and execution of global registration strategies and submission plans.
• Oversee all regulatory submissions, approvals, licenses, renewals, and maintenance activities across global markets.
• Ensure effective planning and execution of FDA, EU MDR, UKCA, Health Canada, PMDA, NMPA, ANVISA, TGA, MDSAP, Saudi FDA, and other international regulatory requirements.
• Provide executive oversight of regulatory operations, labeling compliance, technical documentation, regulatory systems, and submission management activities.
• Drive operational excellence and continuous improvement in global regulatory processes.

Regulatory Intelligence, Policy & External Influence

• Establish and lead a proactive global regulatory intelligence capability to monitor and assess evolving regulatory requirements and industry trends.
• Evaluate the impact of emerging regulations and communicate strategic implications to senior leadership.
• Represent the Company in industry associations, trade organizations, standards committees, and regulatory forums.
• Influence regulatory policy development and contribute to industry best practices through active engagement with external stakeholders.
• Position the Company as a trusted and respected regulatory leader within the global medical device industry.

Health Authority & Notified Body Engagement

• Serve as the primary regulatory representative with FDA, Notified Bodies, Competent Authorities, and other global regulatory agencies.
• Lead executive-level interactions, inspections, agency meetings, consultations, and negotiations.
• Build and maintain strong relationships with regulators and key external stakeholders.
• Advise leadership on regulatory developments, inspection outcomes, compliance risks, and strategic opportunities.
• Ensure effective communication and issue resolution with regulatory authorities worldwide.

Compliance, Quality & Risk Management

• Partner with Quality leadership to ensure alignment between regulatory strategy, product compliance, and quality system requirements.
• Ensure compliance with applicable global regulations and standards, including: FDA regulations, EU MDR and IVDR, ISO 13485, ISO 14971, MDSAP, Global post-market surveillance requirements.
• Support global audit, inspection, CAPA, remediation, and compliance initiatives.
• Provide executive oversight for regulatory risk management and compliance governance activities.
• Ensure organizational readiness for evolving global regulatory requirements.

Mergers, Acquisitions & Strategic Growth

• Lead regulatory due diligence activities for mergers, acquisitions, licensing opportunities, partnerships, and strategic transactions.
• Assess regulatory risks and opportunities associated with new business ventures and portfolio expansion initiatives.
• Support integration of acquired technologies, products, and regulatory organizations.
• Provide regulatory guidance during strategic planning and investment decisions.

Organizational Leadership & Talent Development

• Build, lead, and develop a high-performing global Regulatory Affairs organization.
• Establish organizational priorities, talent strategies, succession plans, and leadership development programs.
• Foster a culture of accountability, collaboration, innovation, inclusion, continuous learning, and operational excellence.
• Lead geographically dispersed teams across North America, Europe, Asia-Pacific, and emerging markets.
• Serve as a mentor and coach to regulatory leaders and future talent across the organization.

Financial & Operational Management

• Develop and manage the global Regulatory Affairs budget and resource plans.
• Establish performance metrics and dashboards to measure organizational effectiveness and regulatory success.
• Ensure efficient allocation of resources to support business priorities.
• Drive continuous improvement, process optimization, and operational scalability across the regulatory function.
• Contribute to enterprise performance objectives as a member of the Science & Technology leadership team.

Leadership Competencies

• Enterprise leadership and strategic thinking.
• Strong business acumen and commercial mindset.
• Exceptional executive presence and influencing skills.
• Ability to translate complex regulatory issues into business decisions.
• Proven ability to build and lead high-performing global teams.
• Strong communication, negotiation, and stakeholder management capabilities.
• Results-oriented with a demonstrated ability to drive organizational performance.
• Effective change leader who thrives in dynamic, rapidly evolving environments.

Success Measures

• Successful execution of global regulatory strategies.
• Achievement of product approval and registration objectives.
• Regulatory compliance and inspection performance.
• Speed and predictability of product approvals.
• Quality and effectiveness of regulatory agency relationships.
• Support of innovation and new product commercialization goals.
• Development and retention of top regulatory talent.
• Contribution to business growth, global expansion, and enterprise value creation.

Qualifications

• Regulatory Affairs Certification (RAC) preferred.
• Experience in Women's Health, Fertility, Reproductive Health, Surgical, Diagnostic, or Medical Device markets preferred.
• Experience working within global publicly traded medical device organizations.
• Demonstrated participation in industry associations, regulatory working groups, or standards organizations.
• 15-20+ years of progressive Regulatory Affairs experience within the medical device, diagnostics, or broader life sciences industry.
• 10+ years of leadership experience directing global regulatory organizations and multi-regional teams.
• Demonstrated success developing and executing global regulatory strategies for complex medical device portfolios.
• Significant experience supporting Class II and/or Class III medical devices across multiple markets.
• Extensive experience leading interactions with FDA, Notified Bodies, Competent Authorities, and international regulatory agencies.
• Proven track record of successfully supporting product development, commercialization, acquisitions, and global market expansion initiatives.
• Experience leading organizations through periods of growth, transformation, and regulatory change.
• Deep expertise in: FDA medical device regulations and regulatory pathways 510(k), PMA, De Novo, IDE, and global submission processes; EU MDR and IVDR requirements; ISO 13485 Quality Management Systems; ISO 14971 Risk Management; MDSAP requirements; Clinical evaluation and performance evaluation requirements; Post-market surveillance and vigilance programs; Labeling and promotional compliance; Global medical device registration and market access requirements.
• Education: Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Pharmacy, or a related scientific discipline required. Advanced degree strongly preferred (MS, PhD, MBA, PharmD, JD, or equivalent).