Regulatory Policy, Standards and Product-related Environmental Protection Specialist

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.

Monitor federal, state/provincial and local product stewardship regulatory developments (i.e., chemicals and restricted substances in products and packaging, energy efficiency, product/packaging/battery recycling, etc.) and monitor federal, provincial/state and local regulatory policy, standards and Product-related Environmental Protection (PEP) developments. ech Canada). Maintain PEP/EHS obligations via SHS compliance registry tools and complete all mandatory reporting. Support customer and regulatory authority assessments.

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.

At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone to grow personally and professionally. Sound interesting? Then come and join our global team as a Regulatory Policy, Standards and Product-related Environmental Protection Specialist to manage compliance with North America (USA and Canada) producer responsibility regulations and support Siemens Healthineers sustainability initiatives.

Our global team: We are a team of more than 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers. 

This is a role well suited to an ambitious professional, looking for the next step in their career. 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:
 

• Monitor federal, state/provincial and local product stewardship regulatory developments (i.e., chemicals and restricted substances in products and packaging, energy efficiency, product/packaging/battery recycling, etc.) via regulation monitoring tools/software and participation in national trade association and customer environmental working groups.

• Monitor federal, provincial/state and local regulatory policy, standards and Product-related Environmental Protection (PEP) developments. These activities include:
  • Proactively track, evaluate and communicate changes in regulatory policy, standards and PEP topics as relevant.
  • Coordinate and communicate SHS participation in industry association activities (e.g. AdvaMed Imaging, AdvaMed, and MedTech Canada).
• Advocate on behalf of SHS to minimize the impact of regulatory developments within NAM, with support of the global SHS PEP team, Legal and SHS NAM sales and service business.

• Maintain current PEP/EHS obligations via SHS compliance registry tools.
• Act as the process owner for PEP activity crafting and managing process documents; performing compliance gap assessments and improvements of internal processes which ensure compliance with existing PEP regulations concerning prohibitions, assembled product and/or component registration, labeling, marketing, sales reporting/fee payment and collection/recycling duties pursuant to extended producer responsibility (EPR).
• Identify and communicate PEP risks to the global business entities and recommend corrective/preventive actions to NAM leadership and the global SHS PEP Team.
• Maintain declarations from SHS factories and third-party suppliers that distribute products and ensure conformance to applicable environmental regulations.
• Qualify and manage disassemblers, recyclers and disposal suppliers. Support customer take-back plans.
• Liaise with environmental authorities and other stakeholders, including hosting audits and responding to PEP information requests raised in customer tenders.
• Provide reports as needed and in a timely manner on regulatory policy, standards and PEP activities. This includes assistance in generating periodic internal reports as well as providing reports (synopsis, outcomes, action items) from meetings, federal, provincial/state and local developments, and all affiliated trade organization teleconferences. This further includes an internal weekly collaboration meeting, periodic newsletter, and maintenance of internal NAM regulatory policy, standards and PEP intranet site.
• Coordinate SHS participation in industry association activities (e.g., AdvaMed Imaging, AdvaMed, and MedTech Canada) and in standards development organizations (e.g., AAMI). This includes representing SHS in such groups, ensuring SME participation when needed, and maintaining internal industry association rosters/SME distribution lists.
• Establish and maintain relationships with internal parties (SMEs) and any affiliated regulatory policy, standards and PEP-related teams.

• Complete and submit internal, federal, provincial/state and local PEP reports on behalf of SHS NAM as required (e.g., PFAS, EPR, Mercury).

• Act as PEP Officer for NAM. Coordinate activities with the global SHS PEP team.
• Coordinate activities with Latin America (LAM) region PEP Officers and the global SHS PEP team.
• Additional responsibilities may be added as needed.

This position may suit you best if you are familiar with below and would like to further develop your career with Siemens Healthineers.
 

• PEP and EPR regulatory policies that identify manufacturers/importers/distributors as responsible parties for their products throughout their lifecycle, including after customers have used them.
• ISO 14001 environmental management system requirements, including identification of relevant compliance obligations; ISO 13485 or 9001 a plus.
• 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, including sales and service.

Required skills for success in this role.

• 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

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The annual base pay for this position is:

Min $124,800 - Max $187,200

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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