Engineer, Material Compliance
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Key skills for this role
Key Skills for This Role
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Duties & Responsibilities
- Determine applicable standards and regulations for each product
- Ensure all product regulatory requirements are identified and met
- Assess and mitigate risks related to global material regulations.
- Analyze product Bill of Materials (BOMs) to identify material compliance gaps
- Coordinate with material suppliers to acquire all relevant compliance documentation.
- Collaborate with other MCE to research and obtain documentation required to bring products into compliance.
- Develop and maintain library of compliance documentation.
- Maintain compliance documentation and update for new and changing regulations.
- Prepare Declaration of Conformity for all relevant products.
- Monitor global regulatory developments and assess product impact.
- Prepare and present product compliance reports
- Evaluate supplier material declarations and ensure compliance documentation meets regulatory requirements
- Conduct material compliance risk assessments and support remediation strategies
Minimum Qualifications
- Bachelor’s degree in Engineering, Science, or related field required.
- 3+ years of experience in product compliance, regulatory affairs, quality engineering, or related functions in a regulated industry.
- Skilled in managing multiple tasks and projects.
- Proficiency with Microsoft Office applications (MS Excel, Access, Word, PowerPoint) and Adobe tools required.
- Experience with Global material restrictions and regulations (RoHS, China RoHS WEEE, REACH, Conflict Minerals, CE mark).
- Strong English proficiency with excellent written and verbal communication skills.
- Experience working with Bill of Materials (BOMs).
- Experience with Agile, third party Roll up tools, and regulatory compliance databases is a plus.
Physical requirements/Work Environment
- This position is located at our Bengaluru, India office.
About Masimo
Medical technology company developing noninvasive patient-monitoring technologies for clinicians and patients worldwide.
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