Environmental & Sustainability Compliance Manager

About this opportunity

The Environmental & Sustainability Compliance Manager will provide global support to multiple Align functions through the implementation of product stewardship processes related to product chemical compliance and sustainability activities. This role acts as a liaison between commercial, legal, operational, and R&D teams to help Align meet compliance and reporting deliverables within commercialization program deadlines. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulations, product stewardship and industrial risk management in the medical device or manufacturing industries. In this role, you will… Establish governance and processes to monitor and assess emerging impacts and risks posed by changing global regulations pertaining to chemical control and reporting, packaging, environmental health, safety (EHS) and sustainability and extended producer responsibility (“EPR”) laws. Identify and communicate compliance with emerging laws, regulations and standards in the areas of chemical regulations, packaging, EHS, sustainability, with a focus on regulations that may impact Align’s existing or planned product lines. Perform risk reviews and business impact assessments on component materials, products, and packaging (g., chemical screening for EH&S impacts, regulatory compliance evaluation, stakeholder perception, product sustainability risk management). Identify and recommend options for mitigating identified risks as they relate to product stewardship, environmental laws and chemical regulatory compliance. Serve as the advisor to the R&D teams to ensure product sustainability, packaging and chemical regulatory compliance requirements are met prior to new product commercialization. Identify and manage relevant compliance risks early in the product life cycle. Working with internal stakeholders, establish governance and processes to ensure that timely compliance with applicable governmental agencies for the regulations they enforce (g., EU REACH, US TSCA, US and EU EPR laws, packaging sustainability) so to enable continued exportation and sales to all global customers. Develop and maintain a database on all safety, health and environmental hazards (g., PFAS), intended uses, and exposures for component materials and new/existing products to support risk characterization and product safety management. Create processes for the timely request, collection and sharing of essential product and component data from the supply chain, while protecting confidential business information. Work with the Supply Chain team to ensure suppliers met our compliance requirements with timely information and documentation. Create and maintain standard operating procedures for the timely audit of suppliers’ compliance and reporting of required information and documentation. Support the development, implementation and maintenance of a corporate-wide database to share product stewardship and compliance records effectively and efficiently. Maintain up-to-date knowledge of current and future product stewardship, chemical regulatory compliance, and sustainability issues through membership in trade associations and external committees, regular review of relevant publications and subscription services, and interactions with external experts and advisors. Advise on the acquisition and management of a software subscription designed to monitor and alert on global regulatory changes. Manage external advisors and consultants on product stewardship, chemical regulatory compliance, and sustainability matters. Regularly report to management on efforts to maintain chemical, EHS, sustainability, product and product packaging compliance. In this role, you’ll need … BS/MS degree in Biochemistry, Chemistry, Toxicology, Chemical Engineering, Law, or related subject. A minimum of 6-10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. Experience with medical device and/or manufacturing businesses and processes is preferable. Knowledge and experience managing compliance with global product regulatory regimes, such as: FDA, Health Canada, European Union REACH, Good Manufacturing Practices (GMP), Global Harmonization System (GHS), Classification for Labelling & Packaging (CLP), Hazard Communication, Hazard Analysis & Critical Control Point (HACCP), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and/or emerging corporate sustainability regulations. Knowledge and experience managing processes and disclosures related to product sustainability attributes and impacts, such as: Life-cycle Assessments (LCAs), Environmental Product Declarations (EPDs), Health Product Declarations (HPDs), Restricted Substances Lists (RSLs), and ISO certifications and other relevant product certification schemes. Ability to read, interpret and operationalize chemical and product sustainability regulations. Demonstrated ability to prioritize and effectively manage a large quantity of ambiguous, complex work using a risk-based approach. Ability to effectively and concisely gather and present information across various levels and product lines of an organization. Demonstrated excellence in verbal and written communication / virtual and in-person presentation skills; clear, succinct, and tailored to audience. Ability to work effectively in a large multinational organization with demonstrated partnering capabilities across a complex stakeholder landscape. Commercial astuteness with the proven ability to appreciate the business and technical requirements required for success. Willingness to travel for work, training, professional society meetings, and product support as needed.