Siemens Healthineers is looking to pioneer breakthroughs in healthcare by managing compliance with North America producer responsibility regulations and supporting sustainability initiatives.
Requirements
- PEP and EPR regulatory policies
- ISO 14001 environmental management system requirements
- Distributor obligations related to product/material safety data sheets
- Federal, provincial, state and local PEP regulatory authorities and reporting requirements
- FDA/Health Canada oversight of the medical device industry
- ISO 13485 or 9001
- Experience with regulation monitoring tools/software
Responsibilities
- Monitor federal, state/provincial and local product stewardship regulatory developments
- Monitor federal, provincial/state and local regulatory policy, standards and Product-related Environmental Protection (PEP) developments
- Advocate on behalf of SHS to minimize the impact of regulatory developments within NAM
- Maintain current PEP/EHS obligations via SHS compliance registry tools
- Act as the process owner for PEP activity crafting and managing process documents
- Identify and communicate PEP risks to the global business entities and recommend corrective/preventive actions
- Maintain declarations from SHS factories and third-party suppliers that distribute products and ensure conformance to applicable environmental regulations
Other
- 10+ years of experience in policy/standards, product safety/compliance, quality assurance or regulatory affairs within a manufacturing industry
- Bachelor's degree in engineering, life sciences, quality/EHS management, public health, health
- Ability to work with controlled technology in accordance with US export control law
- Must be able to provide reasonable accommodations in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process
- Must comply with all United States export control laws and regulations
