Engineer, Regulatory & Product Safety
Masimo is seeking a highly skilled and motivated Engineer, Regulatory & Product Safety to join our dynamic team. As a global leader in noninvasive monitoring technologies, we are dedicated to improving patient outcomes and reducing healthcare costs. In this role, you will play a critical role in ensuring our products meet all regulatory requirements and safety standards. If you are a detail-oriented and collaborative individual with a strong background in engineering and a passion for healthcare, we encourage you to apply.
- Develop and maintain a thorough understanding of regulatory requirements and safety standards for medical devices in various global markets
- Collaborate with cross-functional teams to ensure new and existing products meet all necessary regulatory and safety requirements
- Conduct risk assessments and implement mitigation strategies to ensure product safety
- Prepare and submit regulatory submissions, such as 510(k) and CE mark applications, in a timely and accurate manner
- Review and approve product labeling and promotional materials to ensure compliance with regulatory guidelines
- Monitor changes in regulations and communicate updates to relevant stakeholders
- Conduct internal audits to assess compliance with regulatory and safety requirements
- Participate in external audits and inspections from regulatory bodies
- Maintain and update product technical files and other documentation as required by regulatory agencies
- Collaborate with product development teams to ensure new products are designed and tested according to applicable regulations and standards
- Provide guidance and support to cross-functional teams on regulatory and safety matters
- Continuously identify and implement process improvements to ensure efficiency and compliance with regulatory requirements.
Bachelor's Degree In Engineering, Preferably In A Relevant Field Such As Biomedical, Electrical, Or Mechanical Engineering.
Minimum Of 3-5 Years Of Experience In A Regulatory Or Product Safety Role Within The Medical Device Industry.
Strong Understanding Of Medical Device Regulations And Standards, Including Fda And Iso Requirements.
Experience With Risk Management And Hazard Analysis Processes, Such As Fmea Or Fault Tree Analysis.
Attention To Detail And Strong Analytical Skills, With The Ability To Interpret Complex Technical Documents And Data.
Risk Management
Product Development
Quality Assurance
Project Management
Data Analysis
Technical Writing
Product Testing
Regulatory compliance
Product documentation
Regulatory Standards
Product Certification
Product Safety
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Engineer, Regulatory & Product Safety in Irvine, CA, USA is $80,000 - $120,000 per year. This range can vary depending on the specific industry, company, and level of experience of the engineer. Factors such as education, certifications, and additional skills may also impact the salary range.
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Masimo is an American Irvine, California-based manufacturer of noninvasive patient monitoring technologies. The company sells more pulse oximetry to hospitals than any other company.
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