Director Product Compliance
Caraway Therapeutics, Inc.
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Job summary
Caraway Therapeutics, Inc. seeks a Head of Global Product Compliance & Sustainability to lead the organization-wide framework spanning ideation to post-market surveillance for both electronic and non-electronic products.
The role emphasizes cross-functional leadership across R&D, Quality, Operations, Legal, and Regulatory affairs. The ideal candidate has 10+ years in senior compliance leadership for complex technology-driven products, with experience in global regulatory interfaces, governance
Qualifications
- 10+ years of senior experience in leading global Product Compliance, Environmental Compliance, or Regulatory Affairs within a global organization developing and manufacturing multidisciplinary products.
- 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.
Responsibilities
- 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 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, while increasing overall maturity in compliance and sustainability practices.
Skills
Education
Job description
The Product Compliance & Sustainability lead leads the global Product and Environmental Compliance function across our company AHTS’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.
The role requires strong cross‑functional leadership, deep regulatory and standards expertise, and the ability to translate complex regulatory landscapes into practical, scalable, and auditable business processes across our company AHTS.
The Head of Product Compliance & Sustainability is responsible for defining, driving, and deploying the global product compliance and sustainability strategy across the entire Technology Solutions 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 concept and design through sourcing, manufacturing, market launch, and post‑market surveillance. 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.
Operating within a global matrix organization, the role requires strong cross‑functional leadership, deep regulatory and standards expertise, and the ability to translate complex regulatory landscapes into practical, scalable, and auditable business processes across our company AHTS. The role will collaborate with all product teams within technology solutions.
The role serves as a key interface between R&D, Quality, Operations, and the supporting functions like Regulatory Affairs, legal, Policy & Communication, EHS, and Sustainability, ensuring strategic alignment, proactive regulatory anticipation, and coherent internal and external positioning.
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.
The scope includes software developed in house, through partners, and via third party or open source components, ensuring compliance across software design, development, deployment, operation, maintenance, and decommissioning.
- 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 organizeional 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.
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.
- 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).
- 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.
Regulatory Affairs Certification (RAC) or Certified Compliance & Ethics Professional (CCEP).
Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well‑being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.
Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.
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
US and Puerto Rico Residents Only:
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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/21/2026
The salary range for this role is
$173,200.00 - $272,600.00
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 .
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