JOB OBJECTIVE: Work closely with Quality Assurance / Regulatory Affairs, Engineering, and Manufacturing to provide technical interpretation of domestic and international regulatory requirements for new instrumentation product launches and changes throughout the product lifecycle.
1. Identify applicable regulatory requirements during product development and support compliance activities.
2. Understand new and changing regulations, and determine impact on new and existing products.
3. Participate and/or lead in planning and executing product safety and performance standard testing with third party laboratories.
4. Evaluate product design changes for impact on compliance to applicable regulations and standards.
5. Lead cross-functional initiatives to maintain product licenses and registrations.
6. Support company registrations and device listings in the US, Canada, EU, China, and others as needed.
7. Support creation and maintenance of technical files and Declarations of Conformity in support of EU product registrations/CE Mark.
8. Understand and comply with ethical, legal, quality and regulatory requirements applicable to our business and the products.
1. Support internal and external audits and regulatory inspections.
2. Complete other tasks, as assigned.
1. Bachelor’s Degree (BS) degree 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 61326-1:2013, and safety, including CAN/CSA C22.2 No. 61010-1-12, IEC 61010-1:2010, and UL 61010-1.
4. Extensive knowledge of international regulatory requirements, including FDA, Conflict Minerals, Canada, EU (including RoHS and REACH), China (including China RoHS and CCC), and rest of world.
5. Working knowledge of FDA Quality System Regulations, ISO 13485, and ISO 9001.
6. 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.
7. Excellent written and oral communication skills. Demonstrated ability to read, understand and assist others in development means to comply with regulations while meeting business needs. Able to present information within teams and across groups.
8. Strong interpersonal skills and ability to work independently and cooperatively in teams, including as a project manager.
1. Master’s Degree (M.S.) or greater in engineering or technical discipline.
2. 4 – 6 years of combined Regulatory and Quality experience.
3. Knowledge and experience with medical device standards, including IEC 60601-1.
4. Knowledge and experience with test results being used in successful FDA and rest of world submissions.
1. Ability to use computer and telephone equipment for extended periods of time.
2. Ability to work in a static-free environment wearing personal protective equipment (i.e. ESD gown, wrist strap, etc.).
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.