What are the responsibilities and job description for the Regulatory Affairs and Engineering Lead position at Agile Search Inc.?
Regulatory Affairs and Engineering Lead
We are seeking a skilled Regulatory Affairs and Engineering Lead to play a critical role in advancing technology that directly impacts patient care.
About the Role:
- Lead global material planning and contribute to complex R&D solutions while ensuring compliance with industry regulations.
- Partner with cross-functional engineering teams to analyze components, reduce costs, and standardize specifications.
- Oversight of regulatory compliance related to materials (e.g., REACH, RoHS) and collaboration closely with QA and product development teams.
- Manage end-of-life projections and lead efforts on component replacement strategies.
- Maintain and standardize global parts inventories and develop and deliver training on evolving compliance standards.
- Participate in product development initiatives, ensuring documentation and Design History Files meet FDA QSR and ISO 13485 ISO 9001 standards.
- Conduct internal audits and lead timely, effective corrective action responses.
About You:
- Bachelor's degree in Mechanical, Electrical, BioMedical or Software Engineering (preferred).
- 10 years of experience in complex medical device engineering.
- 8 years in a regulated medical device environment.
- Deep knowledge of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.
- Experience with medical optics, electronics or reusable medical devices is a PLUS.
- Bonus: Ability to evaluate electronic component data sheets in circuit design.
