Engineer, Material Compliance

Masimo Corporation; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A medical technology company located in Bengaluru, India is seeking a Compliance Engineer to ensure that all products meet regulatory standards. The ideal candidate will possess a Bachelor's degree in Engineering or Science and have over three years of experience in product compliance or regulatory affairs. Responsibilities include coordinating with suppliers for documentation, monitoring global regulatory changes, and preparing compliance reports. Strong proficiency in Microsoft Office is required, alongside excellent communication skills.

Qualifications

• 3+ years of experience in product compliance or regulatory affairs.
• Experience with global material regulations like RoHS and REACH.
• Skilled in managing multiple tasks and projects.

Responsibilities

• Ensure compliance with product regulatory requirements.
• Coordinate with suppliers for compliance documentation.
• Monitor global regulatory developments.

Skills

Regulatory compliance

Project management

Proficiency in Microsoft Office

Strong communication skills

Experience with BOM

Education

Bachelor’s degree in Engineering or Science

Tools

Microsoft Office applications

Adobe tools

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

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.