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Engineer, Material Compliance

Open 22d reposted 2× · 2 open copies

Summary

Ensures medical device products meet global material regulations like RoHS and REACH by analyzing BOMs, coordinating with suppliers, and maintaining compliance documentation.

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 & Preferred Qualifications and Experience:

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.

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