Engineer, Material Compliance

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

Job summary

A leading medical technology company in Bengaluru is seeking a compliance specialist to ensure that products meet all regulatory requirements. Responsibilities include analyzing product Bills of Materials, preparing compliance documentation, and monitoring regulatory developments globally. The ideal candidate will have a Bachelor’s degree and at least 3 years of experience in a product compliance role. Strong skills in Microsoft Office and English proficiency are essential. This role offers an opportunity to impact product compliance at a significant level.

Qualifications

• 3+ years of experience in product compliance or regulatory affairs.
• Skilled in managing multiple tasks and projects.
• Strong English proficiency, both written and verbal.

Responsibilities

• Determine applicable standards and regulations for products.
• Ensure compliance documentation meets regulatory requirements.
• Monitor global regulatory developments and assess impact on products.

Skills

Product compliance management

Regulatory affairs

Quality engineering

Strong written communication

Proficiency in MS Office

Experience with BOMs

Agile methodologies

Education

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

Tools

Microsoft Excel

Microsoft Access

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.