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BDPosted 2 weeks ago

Safety Data Sheet Authoring Senior Specialist

$95,600–$153,000 year

On-siteConcord, North Carolina, United States

Full TimeSenior LevelEnterpriseHealthcare Tech

Job Summary

Lead and manage global Safety Data Sheet (SDS) authoring, review, and maintenance in compliance with hazard communication regulations. Serve as the primary Subject Matter Expert for Reagent Hazard Communication, overseeing regulatory compliance data, SAP reporting, and Dangerous Goods classification for road, air, and sea transport. Collaborate cross-functionally with R&D, Manufacturing, and Supply Chain teams to ensure accurate chemical information and support regulatory impact assessments. Coordinate data migration and compilation projects with international sites while managing regulatory training and escalation of compliance issues. Requires 5+ years in Regulatory Affairs or EH&S, with up to 10% travel and 4 days in-office presence in Milpitas, CA.

Required Qualifications

  • Bachelor's degree in Chemistry, Chemical Engineering, Environmental Science, Biology, or a related scientific discipline
  • Minimum of 5 years' experience in Regulatory Affairs, Product Stewardship, or EH&S, with a strong focus on hazard communication
  • Experience with key regulations in North America and Europe, including: US OSHA 2012 Hazard Communication Standard
  • Experience with key regulations in North America and Europe, including: US OSHA 1994 Hazard Communication Standard
  • Experience with key regulations in North America and Europe, including: WHMIS
  • Experience with key regulations in North America and Europe, including: DSD/DPD
  • Experience with key regulations in North America and Europe, including: REACH
  • Experience with key regulations in North America and Europe, including: CLP
  • Knowledge of the UN GHS (Globally Harmonized System)
  • Willingness to travel up to 10% for business purposes
  • Ability to follow verbal and written instructions, manage ambiguity, and work independently with minimal supervision
  • Proven ability to manage multiple priorities in a fast-paced environment
  • Strong organizational skills; fast learner; detail-oriented
  • Strong verbal and written communication skills
  • Good interpersonal skills with the ability to manage and resolve conflict effectively
  • Proficient in personal computing tools, including Microsoft Word, Microsoft Excel, and email applications
  • Minimum of 4 days of in-office presence per week

Desired Qualifications

  • Master's degree preferred
  • SAP knowledge and SDS authoring experience
  • 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 of 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

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