The posting
Job Description
The Global Head of Regulatory Affairs is responsible for establishing and executing the worldwide regulatory strategy across the Company's medical device portfolio, including new product development, global registrations, lifecycle management, market expansion, and post-market compliance activities.
As the Company's senior-most regulatory leader, this role serves as a strategic business partner to the Global Head of Science & Technology and the broader CooperSurgical leadership team, ensuring regulatory excellence while enabling innovation, accelerating global market access, and supporting enterprise growth objectives. The Global Head of Regulatory Affairs provides leadership for all regulatory activities worldwide and is accountable for building a high-performing organization that delivers predictable regulatory outcomes, proactively manages risk, and drives competitive advantage through regulatory strategy.
This position collaborates extensively with Research & Development, Clinical Affairs, Quality, Medical Affairs, Manufacturing, Supply Chain, Legal, Marketing, Commercial, and Product Management organizations to support the successful development, approval, commercialization, and lifecycle management of the Company's products globally.
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:
The Global Head of Regulatory Affairs will be evaluated based on:
- 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).
As an employee of CooperSurgical, you will receive a competitive total compensation plan. Your recruitment team will be able to share more information about any variable pay opportunity and benefit package that accompanies this role. The good faith estimate of the salary range for this role is $220,000 to $350,000 per year. The actual amount offered is determined by a number of factors including but not limited to location, skills and experience.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected].
