New · posted Oct 15
CooperVision · Medical Devices
Vice President, Regulatory Affairs
- Trumbull, CT
- On-site
- Full-time
- VP & Executive
Open until filled
The role
About CooperSurgical:
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
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.
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.
What you need
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.
Pay and benefits
$220,000 – $350,000 a year
Employer providedSuccess 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.
- 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.
Competitive total compensation plan
Variable pay opportunity
Benefit package
Where you'll work
Trumbull, CTOn-siteOpen in Maps (opens in a new tab)
More jobs in Trumbull, CTEqual opportunity, accessibility and legal noticesCooperVision's statements, word for word
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].
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
VP & Executive roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $220,000 | — | $350,000 |
| All US (middle half) | $305,750 | $320,500 | $362,250 |
This role: CooperVision's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not CooperVision's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 56 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership25
- Regulatory submissions12
- GMP and compliance9
- Quality systems and risk6
- Data and digital systems2
- Lab testing and methods1
- Documentation and SOPs1
- Investigations and CAPA1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
CooperVision on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 5
- Locations
By discipline
- Quality9 90%
- Regulatory1 10%
By level
- Senior & Principal8 80%
- VP & Executive1 10%
- Manager1 10%
More roles at CooperVision
- View role
Staff Design Quality Engineer
Trumbull, CTSenior & PrincipalMedical Devices$118K–$150K
- View role
Sr. Computer Systems Validation Engineer
Remote, USSenior & PrincipalMedical Devices$96K–$126K
- View role
Design Quality Engineer II
Trumbull, CTSenior & PrincipalMedical Devices$78K–$100K
- View role
Senior Manager, Global Quality Systems
Trumbull, CT +1 moreManagerMedical Devices$140K–$180K
Similar Regulatory Affairs roles elsewhere
- View role
Vice President, Regulatory Affairs
The Cooper CompaniesTrumbull, CTVP & ExecutiveMedical Devices$220K–$350K
- View role
Head of Regulatory
OverjetSan Mateo, CA · HybridVP & ExecutiveMedical DevicesSalary not listed
- View role
Global Head of Regulatory Affairs, Roche Diagnostics
RocheIndianapolis, INVP & ExecutiveMedical Devices$347K–$455K
- View role
Vice President, MedTech Cardiovascular Regulatory Affairs
IQVIAWashington, DCVP & ExecutiveMedical Devices$169K–$472K
Vice President, Regulatory Affairs at CooperVision
Open until filled. $220K–$350K a year, employer provided.