Engineer, Material Compliance

Masimo Corporation; Bengaluru; On-site; INR 600,000 - 800,000; Full time

Job summary

A leading medical technology company is seeking a compliance specialist to ensure regulatory standards are met for products. Responsibilities include analyzing product compliance, coordinating with suppliers, and preparing compliance documentation. Candidates should have a Bachelor’s degree in Engineering or Science and at least 3 years of experience in regulatory affairs within a regulated industry. Proficiency in Microsoft Office and knowledge of material regulations is essential. This position is based in Bengaluru, India.

Qualifications

• 3+ years of experience in product compliance or related functions in a regulated industry.
• Experience with global material restrictions and regulations (RoHS, REACH).
• Skilled in analyzing Bill of Materials (BOMs).

Responsibilities

• Determine applicable standards and regulations for each product.
• Ensure all product regulatory requirements are identified and met.
• Analyze product Bill of Materials (BOMs) for compliance gaps.

Skills

Project management

Microsoft Office

Regulatory compliance knowledge

Communication skills

Education

Bachelor’s degree in Engineering, Science, or related field

Tools

MS Excel

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.