Regulatory Compliance Senior Specialist
Danaher Corporation
Summary
The Regulatory Compliance Senior Specialist (Product Safety) is responsible for serving as a subject matter expert in product safety compliance, including Safety Data Sheet authoring, hazard communication and applicable global chemical regulations such as GHS, REACH, OSHA (HCS) and related regional requirements. This role leads complex SDS and hazard data activities, supports the Regulatory Compliance Manager with process improvement and strategic alignment, helps ensure regulatory changes are assessed and implemented within WERCS and related team processes, and provides guidance, training, and technical support to colleagues and cross-functional partners.
Job description
This position reports to the Regulatory Compliance Manager (Product Safety), and is part of the Regulatory Compliance, Quality Assurance department located in Waltham, MA and will be an on-site role.
In this role, you will have the opportunity to:
- Lead the generation, maintenance, and ongoing compliance of Safety Data Sheets (SDS) for global markets using WERCS.
- Partner with the Regulatory Compliance Manager to support departmental strategy, process improvements, and alignment with business priorities.
- Monitor regulatory and legislative changes, ensuring timely implementation within WERCS and SDS authoring workflows.
- Provide guidance on SDS authoring, hazard data interpretation, governance requirements, and issue resolution while maintaining product SDS accuracy.
- Manage Service Cloud inquiries, support escalations, and oversee governance and quality checks across antibodies, proteins, peptides, and lysates product portfolios.
The essential requirements of the job include:
- Degree-level education, or equivalent experience in Chemistry, Life Sciences, Regulatory Affairs, Product Compliance, or a related field.
- 4 years of experience in a Regulatory Administrator, Regulatory Affairs, or product compliance role.
- Experience applying global chemical regulations, including EU, CLP (Classification, Labelling and Packaging), GHS, OSHA (HCS), and REACH.
- Demonstrated advanced experience in authoring Safety Data Sheets (SDS) and use of relevant authoring software.
- Ability to work independently, manage competing priorities, and communicate effectively with stakeholders of various levels. High standards of accuracy, attention to detail, and data quality in a fast-paced environment.
It would be a plus if you also possess previous experience in:
- Knowledge of the WERCs software suite.
- Experience acting as an SME or escalation point within a regulatory, product compliance, or product safety team.
Requirements
- Degree-level education, or equivalent experience in Chemistry, Life Sciences, Regulatory Affairs, Product Compliance, or a related field.
- 4 years of experience in a Regulatory Administrator, Regulatory Affairs, or product compliance role.
- Experience applying global chemical regulations, including EU, CLP, GHS, OSHA (HCS), and REACH.
- Demonstrated advanced experience in authoring Safety Data Sheets (SDS) and use of relevant authoring software.
- Ability to work independently, manage competing priorities, and communicate effectively with stakeholders of various levels.
- High standards of accuracy, attention to detail, and data quality in a fast-paced environment.
- Knowledge of the WERCs software suite.
- Experience acting as an SME or escalation point within a regulatory, product compliance, or product safety team.
Benefits
- Paid Time Off
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.