Join a team that is changing millions of lives.
,changing lives.
, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Ourteams are constantly pushing the boundaries of what’s possible.
EnvironmentalSustainability Compliancewill 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,ns,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 regulationspertaining tochemicalcontrol and reporting,packaging, environmental health, safety (EHS)and sustainabilityand 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.
- 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 ensuresuppliers 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 6-10years’ 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/oremergingcorporate sustainability regulations.
- Knowledge and experience managingprocesses anddisclosuresrelated toproduct sustainability attributesand impacts, such as:Life-cycle Assessments (LCAs),Environmental Product Declarations (EPDs), Health Product Declarations (HPDs),Restricted Substances Lists (RSLs), andISOcertificationsand 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.
Great! Click the "Apply" link to let us know you are interested. Not the right fit? Don’t worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.
About Align
. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world’s largest manufacturer of custom 3D-printed materials.
By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work – these are just some of the things employees say make Align Technology a great place to work.
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Global Diversity Statement:
At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. We live our company values by promoting healthy people and healthy communities. All with the intent of changing millions of lives, one unique smile at a time.
It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.
