Regulatory Policy, Standards and Product-related Environmental Protection Specialist

Siemens Healthineers

119d • $124,800 - $187,200

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. As a Regulatory Policy, Standards and Product-related Environmental Protection Specialist in the Siemens Healthineers (SHS) North America (NAM) Sales and Service region, you will be responsible for managing compliance with North America (USA and Canada) producer responsibility regulations and supporting Siemens Healthineers sustainability initiatives. You will monitor federal, state/provincial and local product stewardship regulatory developments and maintain PEP/EHS obligations via SHS compliance registry tools. This position may suit you best if you are familiar with PEP and EPR regulatory policies, ISO 14001 environmental management system requirements, and federal, provincial, state and local PEP regulatory authorities and reporting requirements.

Requirements

• 10+ years of experience in policy/standards, product safety/compliance, quality assurance or regulatory affairs within a manufacturing industry.
• Prior work experience with FDA or industry associations is a plus.
• Bachelor’s degree in engineering, life sciences, quality/EHS management, public health, health.

Nice To Haves

• Familiarity with ISO 14001 environmental management system requirements.
• Knowledge of ISO 13485 or 9001.
• Understanding of distributor obligations related to product/material safety data sheets.
• Experience with FDA/Health Canada oversight of the medical device industry.

Responsibilities

• Monitor federal, state/provincial and local product stewardship regulatory developments.
• Maintain PEP/EHS obligations via SHS compliance registry tools.
• Support customer and regulatory authority assessments.
• Proactively track, evaluate and communicate changes in regulatory policy, standards and PEP topics.
• Coordinate and communicate SHS participation in industry association activities.
• Advocate on behalf of SHS to minimize the impact of regulatory developments within NAM.
• Act as the process owner for PEP activity crafting and managing process documents.
• Perform compliance gap assessments and improvements of internal processes.
• Identify and communicate PEP risks to the global business entities.
• Maintain declarations from SHS factories and third-party suppliers.
• Qualify and manage disassemblers, recyclers and disposal suppliers.
• Support customer take-back plans.
• Liaise with environmental authorities and other stakeholders.
• Provide reports on regulatory policy, standards and PEP activities.
• Coordinate SHS participation in industry association activities and standards development organizations.
• Complete and submit internal, federal, provincial/state and local PEP reports.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term and short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees