We are a small team of very motivated and energetic individuals. We are always seeking to drive speed to market by the least burdensome, but compliant path. We work very closely together on new product development and realization projects and ensure that we support each other in our day-to-day roles and in our department.
As part of our Regulatory Affairs team, you will be an important part of our new laboratory instrumentation product development and realization teams from start to finish making sure all regulatory compliance is met. You will work with cross-functional teams and external testing vendors to ensure that our electronic and electrical equipment complies with international standards and regulations. You don't live in Madison area? This position can be virtual, onsite, or a combination of both!
JOB OBJECTIVE: Work closely with Engineering, Quality Assurance, Regulatory Affairs, and Operations to provide technical interpretation of regulatory and reliability requirements for new instrumentation product launches and changes throughout the product lifecycle.
1. Identify applicable regulatory requirements during product development and support compliance activities related to Promega’s analytical instruments and systems.
2. Understand new and changing regulations and determine impact on new and existing products.
3. Plan and lead Safety and EMC/EMI testing, including collaboration with external test labs.
4. Serve as a key member of cross-functional engineering teams (internal and external) consisting of optical, electrical, software, mechanical, manufacturing, and quality engineers to develop high-performance analytical instruments.
5. Evaluate product design changes for impact on compliance to applicable regulations and standards.
6. Lead cross-functional initiatives to maintain product licenses and registrations.
7. Support company registrations and device listings in the US, Canada, EU, UK, China, and others as needed.
8. Consider all aspects of system reliability including mechanical and electronic failures and user error.
9. Support creation and maintenance of technical files and Declarations of Conformity.
10. Understand and comply with ethical, legal, quality and regulatory requirements applicable to our business and products.
1. Support internal and external audits and regulatory inspections.
2. Support products post-launch by evaluating field failures and recommending specific design improvements.
3. Support preparation of proposals, project plans, and cost estimates.
4. Complete other tasks, as assigned.
1. Bachelor’s Degree (BS) or equivalent in engineering, technical and/or scientific discipline.
2. Minimum 4 years of Regulatory Engineering experience in instrumentation, electrical equipment or safety engineering.
3. Extensive knowledge of key electrical equipment standards for EMC, including EN 61326-1, and safety, including CAN/CSA C22.2 No. 61010-1-12, IEC 61010-1, EN 60825, and UL 61010-1.
4. Extensive knowledge of international regulatory requirements, including FDA, Conflict Minerals, Canada, EU (including RoHS).
5. Proficient in software tools for structured reliability modeling and statistical analysis.
6. Demonstrated ability to perform and/or direct testing, including performance, life, and EMC/EMI.
7. Excellent conceptual, analytical and problem-solving abilities.
8. Working knowledge of FDA Quality System Regulations, ISO 13485, and ISO 9001.
9. Must be able to manage various activities and priorities with minimal direction. Strong attention to detail and sound ability to interpret, translate and address regulatory needs.
10. Excellent written and oral communication skills. Demonstrated ability to comply with regulations while meeting business needs. Able to present information within teams and groups.
11. Strong interpersonal skills and ability to work independently and cooperatively in teams, including as a project manager.
1. Bachelor’s degree (B.S.) or greater in engineering or technical discipline.
2. 4 – 6 years of combined Regulatory and Quality experience.
3. Minimum of 10 years industry experience, with a minimum of 4 years as a reliability engineer or equivalent.
4. Knowledge and experience with medical device standards, including IEC 60601-1.
5. Working knowledge of electronics, enough to understand and assess electronic circuits and hardware designs.
6. Knowledge and experience with test results being used in successful FDA and rest of world submissions.
7. Demonstrated ability to perform and/or direct testing, including performance, life, and EMC/EMI.
8. Proficient in software tools for structured reliability and statistical analysis.
1. Ability to use computer and telephone equipment for extended periods of time.
2. May occasionally lift to 40 pounds.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.