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Masimo Corporation in Bengaluru, India, seeks a Product Compliance professional to determine applicable standards for each product and ensure all regulatory requirements are met. You will assess risks tied to global material regulations, analyze BOMs for compliance gaps, and coordinate with suppliers to secure necessary documentation.
You will develop and maintain a comprehensive compliance documentation library and prepare Declarations of Conformity while monitoring evolving global regulations
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
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.
This position is located at our Bengaluru, India office.