Regulatory Compliance Engineer - United States
- Key Role for the development and execution of product regulatory compliance programs within Microbial Solutions.
- Ensures product compliance by researching and identifying applicable regulatory and industry compliance standards and codes.
- Develops compliance polices and strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide input to create and implement regulatory compliance plans for product development programs
- Identifies compliance related risks, effectively communicates and develops approaches to avoid or reduce the risk
- Provide regulatory interpretation support and guidance to design and test engineers
- Participates with compliance plan reviews and safety design review meetings for products, early in the design cycle
- Facilitate product and system testing internally and externally to ensure regulatory compliance in the target markets, while creating and focusing on quality, cost and schedule goals
- Perform all other related duties as assigned
- Education: Bachelor’s degree in Engineering, Manufacturing Engineering, Biomedical, Science, Physics or other technical discipline. Equivalent work experience will also be considered
- Experience: 3+ years’ experience on regulatory complianc3e, on both software and hardware based products.
- Must possess experience in providing direction and taking the lead on regulatory input during the product design process.
- Exposure to ESD, EMC, EMI and product safety testing and country certifications or homologations
- Understands manufacturing and supply chain issues as they relate to phase-in of compliance-driven design changes
- Ability to explain and document regulatory and standards requirements
- Demonstrated strong and effective verbal, written, and interpersonal communication skills, enabling effective technical discussions with design and test engineers, labs and EU authority engineers.
- Previous experience with FDA and/or CDRH approvals and reporting as well as efforts on EMC and/or Product Safety certifications is highly preferred .
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None .