Material Compliance Engineer

Its fun to work in a company where people truly BELIEVE in what they are doing!

Were committed to bringing passion and customer focus to the business.

Responsibilities (KRAs / deliverables/job expectations):

• 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.
• Monitor prioritize and coordinate responses to customer requests for material compliance declarations and documentation.
• Conduct supplier assessments audits and follow-ups as necessary to verify compliance with applicable material regulations.
• Review supplier documentation including declarations test reports and chemical content information.
• Collaborate with procurement R&D manufacturing and regulatory teams to ensure materials and products meet all compliance requirements.
• Maintain and update regulatory databases and track changes in applicable legislation.
• Prepare and provide internal and external compliance reports including material declarations and customer-facing certifications.
• Support regulatory submissions technical files and MDR documentation related to material compliance.
• Provide training and guidance to internal teams on material compliance requirements.
• Investigate and respond to material compliance issues including nonconformance product recalls or customer inquiries.
• Monitor industry trends and participate in professional forums to remain current on evolving material regulations.
• 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):

• Minimum 35 years of experience in material compliance preferably in the medical device electronics or regulated manufacturing industry.
• Experience managing supplier compliance programs and maintaining regulatory documentation.
• Familiarity with customer audits and regulatory inspections related to material compliance.
• 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 youll enjoy your career with us!

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