Director Product Compliance
PharmaRegulatory AffairsQuality Assuranceheoremacroraveinformaws
Job description
Job Description Tech Solutions Product Compliance & Sustainability Global Lead Role Purpose: The Product Compliance position 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. 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 (covering both electronic and non‑electronic products). Also 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, and 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. Key Responsibilities: Strategic Leadership & Governance: 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. 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. 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). 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. 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 across relevant organizational functions, including engineering, R&D, procurement, and product teams. Draft and maintain compliance policies, SOPs, work instructions, and templates. A
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Associate, Project Management (Pharmaceutical Labeling)
Open Scientific — Hauppauge, us
Maintenance Coordinator
Open Scientific — Bohemia, us
Manufacturing Operators - Pharmaceutical
Open Scientific — Melville, us
Pharmaceutical Mechanics - Packaging, Production, Maintanence
Open Scientific — Hauppauge, us
Warehouse - Pharmaceutical
Open Scientific — Hauppauge, us
Pharmaceutical Machine Operators
Open Scientific — Hauppauge, us