Director Product Compliance

• Define and lead a global Product Compliance strategy aligned with our company 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 organizaional 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, while increasing overall maturity in compliance and sustainability practices. 

• 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. 

• AI/algorithm governance where applicable. 

• Define and embed compliance processes within: 

• Product development and design. 

• Material and component selection. 

• Supplier onboarding and qualification. 

• Production Readiness Reviews (PRR). 

• Ongoing post‑launchcompliance monitoring. 

• Ensure robust data management, traceability, and documentation that supports 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 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. 

• Develop and deploy global training programs to translate regulatory requirements into practical guidance for across 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.  

• 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. 

• Partner closely with our company 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. 

Bachelor’s degree in Engineering (Mechanical, Electrical, or Software), Computer Science, or a related technical discipline.

Master’s degree (M.S.) in Regulatory Affairs, Engineering Management, or Business Administration (MBA).

Regulatory Affairs Certification (RAC) or Certified Compliance & Ethics Professional (CCEP).

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• 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. 

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.