Director Product Compliance
MSD
Summary
Lead the global Product and Environmental Compliance function across the Technology Solutions product portfolio, covering electronic and non-electronic products. Establish a unified, end-to-end compliance framework spanning the entire product lifecycle from ideation to commercial release and post-market surveillance.
Job description
Role Purpose
Lead the global Product and Environmental Compliance function across the Technology Solutions product portfolio, covering electronic and non-electronic products. Establish a unified, end-to-end compliance framework spanning the entire product lifecycle from ideation to commercial release and post-market surveillance.
Role Overview
Define, drive, and deploy the global product compliance and sustainability strategy across the Technology Solutions product portfolio. Establish a unified compliance framework spanning concept and design through sourcing, manufacturing, market launch, and post-market surveillance, covering legacy products, new product development, engineering change management, and market extensions. Operate within a global matrix organization, collaborating with R&D, Quality, Operations, Regulatory Affairs, Legal, Policy & Communication, EHS, and Sustainability. Scope includes software products such as embedded firmware, device software, cloud services, mobile and web applications, data platforms, and AI-enabled functionalities.
Key Responsibilities
- Define and lead a global Product Compliance strategy aligned with business objectives, product portfolio, and risk profile.
- Establish governance including scope definition, decision rights, escalation paths, and accountability across Compliance, Legal, R&D, Engineering, Supply Chain, Quality, Product, Marketing, and EHS.
- Transition the organization from a reactive to a proactive, risk-based compliance model.
- Serve as a senior advisor to leadership on regulatory risk, market access, and product compliance strategy.
- Lead and coordinate an international network of Compliance and Sustainability functions.
- Influence without direct line authority to ensure alignment across local and global teams.
- Build and strengthen a product compliance culture and increase maturity in compliance and sustainability practices.
- Oversee regulatory monitoring, assess regulatory and standards changes, conduct impact assessments, and define multi-year implementation roadmaps.
- Lead product certification and conformity assessment requirements for international regulations, standards, and market access rules.
- Maintain expertise in software-related regulations including cybersecurity, privacy, data protection, software safety, reliability, update obligations, and AI/algorithm governance.
- Embed compliance processes in product development, material and component selection, supplier onboarding, production readiness reviews, and post-launch monitoring.
- Ensure data management, traceability, and documentation supporting audits, regulatory inquiries, and customer requests.
- Own compliance-related KPIs, coverage metrics, and reporting.
- Lead supplier engagement and compliance data collection across a global multi-tier supply chain.
- Define compliance requirements and clauses in supplier contracts.
- Oversee platforms for supplier compliance data and improve response rate, data quality, and transparency.
- Develop and deploy global training programs for engineering, R&D, procurement, and product teams.
- Draft and maintain compliance policies, SOPs, work instructions, and templates.
- Act as a Center of Excellence for compliance-related cases and queries.
- Define and lead the Software Compliance Framework across the software lifecycle.
- Act as primary compliance interface for software-related audits, customer inquiries, and regulatory inspections.
- Partner with Manufacturing, Global Supply Management, EHS, Policy & Communications, Legal, and other corporate functions.
- Support M&A, due diligence, and business development from a product compliance perspective.
- Interface with regulators, notified bodies, certification labs, and industry organizations.
Minimum Education
Bachelor's degree in Engineering (Mechanical, Electrical, or Software), Computer Science, or a related technical discipline.
Preferred Education
Master's degree (M.S.) in Regulatory Affairs, Engineering Management, or Business Administration (MBA).
Required Qualifications
- 10+ years of senior experience leading global Product Compliance, Environmental Compliance, or Regulatory Affairs within a global organization developing and manufacturing multidisciplinary products involving mechanics, electronics, and software.
- Strong background managing regulatory compliance and product certification/standards for complex technology-driven products in multiple jurisdictions.
- Proven experience with external compliance and regulatory interfaces such as regulators, certification labs, notified bodies, and industry organizations.
- Proven ability to lead cross-functional matrix organizations without direct authority.
- Demonstrated experience building governance models, compliance policies and procedures, and product compliance data frameworks from the ground up.
- Strong risk-based mindset and ability to balance regulatory rigor with business needs.
- Excellent communication and stakeholder-management skills at executive level.
- Fluency in English and experience working in a global, multicultural environment.
Preferred Certifications
Regulatory Affairs Certification (RAC) or Certified Compliance & Ethics Professional (CCEP).
Requirements
- Bachelor's degree in Engineering (Mechanical, Electrical, or Software), Computer Science, or related technical discipline
- 10+ years of senior experience in global Product Compliance, Environmental Compliance, or Regulatory Affairs
- Experience in a global organization developing and manufacturing multidisciplinary products involving mechanics, electronics, and software
- Strong background in regulatory compliance and product certification/standards for complex technology-driven products in multiple jurisdictions
- Experience working with regulators, certification labs, notified bodies, and industry organizations
- Proven ability to lead cross-functional matrix organizations without direct authority
- Demonstrated experience building governance models, compliance policies and procedures, and product compliance data frameworks
- Strong risk-based mindset and ability to balance regulatory rigor with business needs
- Excellent communication and stakeholder-management skills at executive level
- Fluency in English
- Experience working in a global, multicultural environment
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.