IT Compliance & Validation Specialist ensuring IT compliance within GMP - regulated environments and performing risk analyses. Join Amapharm's mission and enjoy a range of employee benefits.
About the role
- Senior Product Environmental Compliance Specialist leading compliance initiatives in Stryker's Endoscopy division. Driving regulatory strategy and cross‑functional alignment in a hybrid role.
Responsibilities
- Serve as the divisional Subject Matter Expert for Product Environmental Compliance (PEC)
- Act as the Endoscopy Division’s Process Owner for PEC, advising corporate and advocacy partners
- Monitor emerging PEC directives and regulatory updates; assess business impact, recommend risk mitigation
- Lead and collaborate with engineering, regulatory, quality, sourcing, operations, and suppliers
- Integrate PEC requirements into New Product Development processes
- Manage third‑party PEC evidence partners, oversee data integrity and trending
Requirements
- Bachelor’s degree
- Minimum of 2 years of experience within a regulated industry
- Strong organizational, analytical, and problem‑solving skills
- Preferred Bachelor’s degree in environmental science, material science, engineering, pharmaceutical sciences, or related field
- Experience in the medical device industry or other highly regulated fields (automotive, pharmaceutical, aerospace)
- Knowledge of environmental regulations (RoHS, REACH, TSCA, EU MDR Restricted Substances, EU Packaging, Stockholm Convention, etc.)
- Certifications such as NREP, CECM, or CEP
- Experience analyzing non‑routine regulatory issues and resolving complex compliance challenges
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Bonus eligible
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