
Director Product Compliance
Merck
Summary
The Product Compliance position leads the global Product and Environmental Compliance function across the company's product portfolio, covering both electronic and non-electronic products. This role is accountable for establishing a unified, end-to-end compliance framework that spans the entire product lifecycle—from Ideation to Commercial Release and post-market surveillance.
Job description
Role Purpose
The Product Compliance position leads the global Product and Environmental Compliance function across the company's product portfolio, covering both electronic and non-electronic products. This role is accountable for establishing a unified, end-to-end compliance framework that spans the entire product lifecycle—from Ideation to Commercial Release and post-market surveillance.
Role Overview
This role is responsible for defining, driving, and deploying the global product compliance and sustainability strategy across the entire Technology Solutions product portfolio. The scope explicitly covers legacy products, new product developments (R&D), engineering change management (ECM) activities, and market extensions of existing products into new geographies or applications. The role additionally covers products containing software, including embedded firmware, device software, cloud based services, mobile and web applications, data platforms, and AI enabled functionalities.
Key Responsibilities
Strategic Leadership & Governance
- Define and lead a global Product Compliance strategy aligned with business objectives, product portfolio, and risk profile.
- Establish clear governance, including scope definition, decision rights, escalation paths, and accountability across Compliance, Legal, R&D, Engineering, Supply Chain, Quality, Product, Marketing, EHS.
- Transition the organization from a reactive to a proactive and risk-based compliance model.
- Serve as a senior advisor to leadership on regulatory risk, market access, and product compliance strategy and implementation.
- Lead and coordinate an international network of Compliance and Sustainability organizational functions.
- Influence without direct line authority, ensuring alignment and buy-in from both local and global teams.
- Contribute to building, sustaining, and continuously strengthening a strong product compliance culture across the organization.
Regulatory & Subject Matter Expertise
- Ensure regulatory compliance throughout the entire product lifecycle (design, development, industrialization, market release, engineering changes, market extensions and end-of-life).
- Oversee regulatory monitoring activities, assess regulatory and standards changes, conduct regulatory impact assessments, and define multi year implementation roadmaps.
- Maintain expert level understanding of global product related regulations and ensure effective interpretation and implementation across the organization.
- Lead Product Certification and conformity assessment requirements, ensuring compliance with international regulations, standards and market access rules.
- Maintain expert level understanding of software related regulations, standards, and frameworks, including cybersecurity, privacy, and data protection requirements; software safety, reliability, and update obligations; and AI/algorithm governance where applicable.
Processes, Data & Systems
- Define and embed compliance processes within product development and design, material and component selection, supplier onboarding and qualification, Production Readiness Reviews (PRR), and ongoing post-launch compliance monitoring.
- Ensure robust data management, traceability, and documentation that supports audits, regulatory inquiries, and customer requests.
- Own compliance-related KPIs, coverage metrics, and reporting.
Supply Chain & Supplier Compliance
- Lead supplier engagement and compliance data collection across a global, multi-tier supply chain.
- Define compliance requirements and clauses in supplier contracts.
- Oversee the use of the company's platforms for obtaining and updating suppliers' compliance data and drive improvements in supplier response rate, data quality, and transparency.
Training, Communication & Change Management
- Develop and deploy global training programs to translate regulatory requirements into practical guidance for relevant organizational functions, including engineering, R&D, procurement, and product teams.
- Draft and maintain compliance policies, SOPs, work instructions, and templates.
- Act as a Center of Excellence for addressing and resolving compliance-related cases and queries.
Software, Digital & Cyber Compliance
- Define and lead the Software Compliance Framework.
- Ensure compliance across the software lifecycle.
- Act as the primary compliance interface for software-related audits, customer inquiries, and regulatory inspections.
Global & External Interfaces
- Partner closely with global organizational functions, including Manufacturing, Global Supply Management, Environment Health and Safety, Policy & Communications, Legal and other corporate functions.
- Support M&A, due-diligence, and business development activities from a product compliance perspective.
- Interface with regulators, notified bodies, certification labs, and industry organizations as required.
Requirements
- Bachelor's degree in Engineering (Mechanical, Electrical, or Software), Computer Science, or a related technical discipline
- 10+ years of senior experience in 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 in managing both regulatory compliance and product certification/standards for complex, technology-driven products in multiple jurisdictions
- Proven experience in working 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 in 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; experience working in a global, multicultural environment required
- Compliance Policies
- Conformance Testing
- Control Monitoring
- Government Regulation
- Information Security
- Knowledge of regulations and frameworks
- Legal Compliance
- Product Compliance
- Regulatory Management
- Regulatory Risk
- Standards Compliance
- Strategic Leadership
- Vendor Management
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.