Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people. At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster. Our Values include:
Resilient Growth Mindset
Executional Excellence
Courageous Leadership
Inclusive Collaboration
We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.
The Product Safety & Compliance Manager will analyze and communicate health and environmental hazards of products for their life cycle as it relates to manufactural sites’ within the AMER region and market regulations impacting products distributed globally. Additionally the analysis and communication of transport hazards for all transportation routes belongs to this role. The Product Safety manager monitors the constantly changing regulations and provides the appropriate hazard communications to comply with these regulations.What you will be doing:
Perform a full gap assessment on the process & product lines offered by both Kalamazoo, MI and Portsmouth, NH sites (Kalamazoo product focus in phase 1) as it relates to Product Safety & Compliance (ex. REACH, Prop 65, etc.).
Execute the remediation with the end goal of having a well-documented and maintained Product Safety and Compliance process that allows us to compliantly and effectively monitor product compliance and issue resultant documentation/records, upon request.
Act as part of the Global Compliance Network which has individuals with similar responsibilities in the other regions getting together to monitor and guide the overall process for Epredia.
Perform hazard determinations, author regionally compliant SDSs, guide labeling specialists to develop compliant primary, secondary, and tertiary product labels and inserts, and other regulatory documents.
Manage a process to create, maintain and distribute SDSs both internally to employees and externally to customers in compliance with relevant regulatory requirements including but not limited to, OSHA GHS, REACH CLP, Proposition 65 and Canadian WHMIS.
Establish and maintain product composition database for both chemical consumables under the REACH directive as well as equipment falling under RoHs.
Guide labeling specialists to develop compliant primary, secondary, and tertiary product labels and inserts.
Maintain knowledge with changing global regulations and communicated proposed and impending changes to leadership to ensure business continuity and compliance.
Perform product hazard classifications for DOT/FAA compliance
Interface with FAA/DOT/OSHA/DEA and other regulatory bodies regarding product safety compliance.
Oversee other Kalamazoo, MI compliance requirements including Alcohol and Tobacco Tax and Trade Bureau (TTB) and DEA.
May have 1-2 direct reports
Skills you will need:
Bachelor’s Degree
5+ years experience required
Experience working within an ISO environment (ISO 13485, 9001, 15378, 22000, etc.)
Experience working with in a regulated environment (FDA, IVDR, etc.)
Experience with SDS development using UL Wercs eLite software.
Experience with SAP queries and product BOM reports.
Strong experience in root cause analysis and continuous improvement.
Experience with system development and project management
Ability to work flexible schedule.
Ability to set priorities and make decisions in a dynamic work environment.
Must be able to lift up to 40 lbs
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
