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 & 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.
Masimo (NASDAQ: MASI) is a global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies, including medical devices and a wide array of sensors. Our work is making a measurable difference in the world by saving, extending and improving the lives of people of all ages, in all walks of life
For more than 30 years, our innovative medical technologies and noninvasive patient monitoring solutions have been solving ‘unsolvable’ problems. The result is a portfolio of clinically-proven products that lead the way in innovation, performance and patient safety by giving health care providers the information they need to optimize clinical decision-making.
Masimo is for‘what-ifers’, ‘never-say-never-ers’, and ‘world changers’—people who look beyond what others see. We're looking for people who can, do, and will make a difference.
We think you'll like what you see.
