If you're a Regulatory Affairs Engineer with several years of experience in Medical Device and Instrumentation, we have an amazing role for you!
What You'll Do:
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.
In this role you'll be able to 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. Key responsibilities include:
1. Identify applicable regulatory requirements during product development and support compliance activities related to the company's analytical instruments and systems.
2. Understand new and changing regulations for electrical and electronic equipment and in vitro diagnostic medical devices to determine impact on new and existing products.
3. Plan and lead Safety, Laser 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 medical 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. Author content and seek input from others on the creation and maintenance of technical files in support of Declarations of Conformity.
10. Support internal and external audits and regulatory inspections.
11. Support products post-launch by evaluating field failures and recommending specific design improvements.
12. Support preparation of proposals, project plans, and cost estimates.
13. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others.
14. Embracing and being open to incorporating the company's Emotional & Social Intelligence (ESI) core principles in daily work.
15. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
What You'll Bring:
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. 4 – 6 years of combined Regulatory and Quality experience.
2. 10 years industry experience, with a minimum of 4 years as a regulatory engineer or equivalent.
3. Knowledge and experience with medical device standards, including IEC 60601-1.
4. Working knowledge of electronics, enough to understand and assess electronic circuits and hardware designs.
5. Knowledge and experience with test results being used in successful FDA and rest of world submissions.
Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.