Sr Manager, Chemical Compliance

Role Summary

This position is responsible for development, oversight, and tactical implementation of Hologic's global strategy for Chemical Compliance. Acting as a subject matter expert and proactive program leader, the Senior Manager Chemical Compliance will provide collaborative support to all Hologic divisions as well as coordinating projects requiring in-depth understanding of chemical regulations and cross-divisional scope. The applicant will lead a team to bridge materials science, chemical safety, and medical device regulations (such as FDA, EU MDR, and ISO standards) to guarantee products are safe for patients and compliant across international markets. The core focus includes tracking restricted substances, evaluating material compositions, managing technical documentation, and supporting product life-cycle updates.

Essential Duties and Responsibilities

• Develop, influence and continuously improve the global Chemical Compliance strategy and program
• Develop, refine and maintain training on corporate standards for meeting the company's Chemical Compliance obligations
• Analyze Bills of Materials (BOMs), material safety data sheets (MSDS/SDS), and supplier disclosures
• Collaborate with quality and R&D teams to align chemical profiles with ISO standards and risk management framework
• Prepare compliance declarations, technical files, REACH/RoHS reports, and support regulatory audits or FDA/CE submissions
• Partner with procurement, R&D, and external suppliers to source compliant parts, collect chemical data, and manage Engineering Change Orders (ECOs) via PLM systems (e.g., Oracle Agile, SAP)
• Lead complex impact assessments for newly restricted substances (e.g., PFAS) and manage escalation paths for supply chain disruptions
• Lead cross-functional alignment with Quality Assurance (QA) and Regulatory Affairs (RA) to integrate chemical compliance into Quality System programming
• Set compliance requirements for procurement and strategic sourcing, driving accountability across the global supplier network
• Champion the deployment and/or optimize Product Lifecycle Management (PLM) or compliance database software solutions (e.g., Enhesa, Assent, Source Intelligence, Watershed, SAP, etc.) to automate tracking
• Provide leadership and consulting support for the hazardous communication program
• Support global Safety Data Sheets (SDSs) and product label programs for compliance with regional GHS revisions (e.g., OSHA HCS in the US, EU CLP, China GHS). Support the evolution and update of the global strategy for SDS authoring, management, and distribution in compliance with evolving regional GHS standards
• Support the enterprise SDS authoring platforms (e.g., SAP EHS, Sphera, Werks) and relationships with third-party translation and chemical toxicology vendors
• Support workflows to capture, maintain, and update Hazard Communication documentation for hazardous chemical components used within our product portfolio
• Partner with R&D during early-stage product design to assess the chemical regulatory impact of new materials, coatings, and reagents
• Support end to end strategy including effective ownership of Non conformances related to: Chemical Compliance system, process and vendor, oversight, and distribution of KPIs; development and maintenance of Corporate Chemical Compliance Procedures
• Provides subject matter expertise as needed for major filings (e.g. Substance wide Registrations, Authorization Applications, Pre-Manufacturing Notices, etc.)
• Serve as expert business liaison across the Hologic
• Participate in Divisional Chemical Compliance Progress reviews
• Support and provides expertise during internal and external audits related to Chemical Compliance Process and System (MDR certification/ISO audits, etc.)
• Management and oversight of third-party vendors associated with Chemical Compliance Activities/Process
• Provide visibility to leadership and divisional stakeholders on the performance of the Chemical Compliance program
• Participates in due diligence and integration activities as required

Education

BS/MS/PhD degree in Materials Engineering, Biochemistry, Chemistry, Toxicology, Chemical Engineering, Law or related field.

Experience

• Bachelors and 10+ years of experience or Master's degree and 7+ years of experience with a minimum of 3 - 5 years' experience in chemical regulatory compliance function
• Minimum 1-3 yrs experience in managing people
• The applicant should have a broad understanding of global chemical control regulations such as REACH, RoHS, EU MDR and IVDR Hazardous Substances, California Proposition 65, TSCA, PFAS, POPs, and Restricted Substances

Skills

• Demonstrated experience working with the scope of international chemical and/or environmental product regulations
• Demonstrated ability to effectively work within a global environment
• Experience with trade associations and/or sectorial advocacy groups
• Effective in the education, interpretation, and successful operationalization of chemical regulations
• Effective cross functional partner with keen ability to influence and drive results through others
• Can effectively and concisely present information across all levels of the organization
• Able to concurrently oversee/contribute to multiple large-scale projects

Soft Skills

• Results-orientated
• Critical Thinker
• Greets challenge and change as opportunity
• Anticipates needs and problems while creating innovative solutions
• Committed to integrity
• Customer centric
• Ability to thrive in a dynamic environment with initiative and leadership
• People development

Travel: ~ 10% travel