It's fun to work in a company where people truly BELIEVE in what they are doing!
We're committed to bringing passion and customer focus to the business.
Responsibilities (KRAs / deliverables/job expectations):
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Develop, implement, and maintain company-wide material compliance programs for regulations and database maintenance for regulations such as California Prop 65, REACH, RoHS, Conflict Minerals, TSCA, PFAS, SCIP, Latex, CMDR etc.
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Monitor, prioritize and coordinate responses to customer requests for material compliance declarations and documentation.
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Conduct supplier assessments, audits, and follow-ups as necessary to verify compliance with applicable material regulations.
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Review supplier documentation, including declarations, test reports, and chemical content information.
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Collaborate with procurement, R&D, manufacturing, and regulatory teams to ensure materials and products meet all compliance requirements.
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Maintain and update regulatory databases and track changes in applicable legislation.
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Prepare and provide internal and external compliance reports, including material declarations and customer-facing certifications.
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Support regulatory submissions, technical files, and MDR documentation related to material compliance.
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Provide training and guidance to internal teams on material compliance requirements.
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Investigate and respond to material compliance issues, including nonconformance, product recalls, or customer inquiries.
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Monitor industry trends and participate in professional forums to remain current on evolving material regulations.
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The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.
Experience (exposure):
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Minimum 3–5 years of experience in material compliance, preferably in the medical device, electronics, or regulated manufacturing industry.
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Experience managing supplier compliance programs and maintaining regulatory documentation.
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Familiarity with customer audits and regulatory inspections related to material compliance.
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Knowledge of global material regulations and medical device regulatory standards with ability to interpret changes in law.
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
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