Engineer, Material Compliance

Masimo; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Masimo Bengaluru is seeking a Regulatory Compliance Specialist to determine applicable standards for each product and ensure all regulatory requirements are met. The role involves risk assessment for global material regulations and maintaining a robust library of compliance documents.

You will coordinate with suppliers and cross-functional teams to obtain necessary documentation and prepare conformity declarations, monitoring changes in global regulations and reporting findings.

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.
• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint) and Adobe tools required.
• Experience with Global material restrictions and regulations (RoHS, REACH, WEEE, CE mark) preferred.
• Strong English written and verbal communication skills.

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 BOMs to identify material compliance gaps.
• Coordinate with suppliers to acquire compliance documentation.
• Collaborate with MCE to obtain documentation for regulatory compliance.
• Develop and maintain library of compliance documentation.
• Maintain and update compliance docs for new regulations.
• Prepare Declarations of Conformity for relevant products.
• Monitor regulatory developments and assess product impact.
• Prepare and present product compliance reports.
• Evaluate supplier declarations and ensure documentation meets requirements.
• Conduct material compliance risk assessments and support remediation strategies.

Skills

Regulatory affairs

Project management

Written and verbal communication

English proficiency

BOM experience

Regulatory databases

Education

Bachelor's degree in Engineering/Science

Tools

MS Excel

Adobe tools

MS Word/PowerPoint

Job description

Job Description

• 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

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

Minimum & Preferred Qualifications and Experience:

• 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.