Senior Product Stewardship Specialist

Senior Product Stewardship Specialist

The Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global product distribution and ensure ongoing regulatory compliance. This role is responsible for maintaining high‑quality regulatory and product data across internal systems, enabling compliant global commercialization and lifecycle management.

Job Title: Senior Product Stewardship Specialist

Location: Poland, Europe

About the Job

The Senior Product Stewardship Specialist is the business lead and primary point of contact for Reagent Hazard Communication. This role serves as a Subject Matter Expert (SME) and works cross‑functionally to plan, implement, and manage Product Stewardship activities, with a strong focus on Global SDS Authoring, Hazard Communication, and Dangerous Goods compliance. The position also provides guidance on activities involving Materials of Concern (MOC).

This is an outstanding opportunity to collaborate with an exceptionally ambitious and globally connected team.

Key Responsibilities

• Hazard Communication & SDS Management
• Regulatory Compliance & Product Stewardship
• Dangerous Goods & Cross‑Functional Support
• Data Coordination & Training

Minimum Qualifications

• Education & Experience
• Skills & Competencies

Preferred / Desired Knowledge and Skills

• Background in Medical Device Reagent design and/or manufacturing.
• Knowledge of Dangerous Goods transportation regulations, including IATA, DOT, and ADR.
• Understanding of California Proposition 65 risk assessment and labeling requirements.
• Knowledge of chemical and hazard communication regulations in Eastern Europe and the Asia‑Pacific region.
• Familiarity with U.S., state, and international chemical inventory lists.
• Knowledge of U.S. and international chemical waste regulations.
• Understanding of toxicology and ecotoxicology relevant to SDS authoring.
• Experience with master data management in a manufacturing or biotech environment.
• Strong data analysis skills, including advanced use of Excel, Access, or similar data management tools for data manipulation and transformation.