Sr. RA Specialist- Product Environmental Compliance
Share
Job Location:
Monthly Salary:
Posted on:
05-11-2025
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Hybrid
What you will do-
- Possesses and applies a broad knowledge and understanding of the product environmental compliance requirements legislation processes and procedures.
- Experienced with BOMCheck gap assessment for supplier declarations and updating corresponding environmental summary reports.
- Performs the coordination and preparation of document packages for evidence related to product environmental regulations to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
- Coordinates schedules prepares and compiles documents for review & submission to regulatory agencies. Identifies / supports procedural updates changes in labeling manufacturing processes and participates in development and implementation of the same. Keeps abreast of regulatory/ State of the art changes.
- Possesses and applies a broad knowledge and understanding of regulations processes and procedures. Judgement in applying professional expertise and is expected to work independently with minimal supervision. Communicate and collaborate internally and externally during product development process.
- Conducts analytical research and provides expertise on product environmental compliance requirements to get market access for new and existing products.
What you will need-
Required-
- This position requires professional mastery of a specialized field of engineering that requires a bachelors degree in mechanical engineering Electrical Engineering Science environmental science or equivalent focus or equivalent certification.
- Requires a minimum of 5 or more years Regulatory or Product Environmental Compliance or equivalent experience within medical device company or similar organization.
- Knowledge of applicable medical device and environmental regulations & standards (21CFR MDD & EU MDR GSPR checklist QSR ISO 13485 ISO 14971 PFAS California Prop 65 REACH EU POPs RoHS WEEE BWWR Packaging & Packaging Waste Regulation Battery Checklist Industry Specific Substances Restrictions and Declarations etc.)
Preferred-
- Professional knowledge gained through substantial applicable work experience to supplement formal knowledge to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive.Advanced PC skills with proficiency in Microsoft Office Suite including Excel Power BI.
- Knowledge of applicable environmental regulations for US and OUS- PFAS REACH RoHS WEEE BWWR Packaging & Packaging Waste Regulation Biocompatibility Battery Checklist etc.)
- Has experience in product environmental compliance (PFAS California Prop 65 REACH EU POPs RoHS WEEE BWWR Packaging & Packaging Waste Regulation Battery Checklist Industry Specific Substances Restrictions and Declarations etc.) and is also competent in EU MDR US FDA & other regulations.
Required Experience:
Senior IC
Key Skills
- Floor Care
- Hospital Experience
- Hospitality Experience
- Computer Skills
- Environmental Services
- Cleaning Experience
- OSHA
- Contract Management
- Team Management
- Custodial Experience
- EHS
- Commercial Cleaning
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
