Magic Leap is seeking a Regulatory Affairs Sr. Manager with experience working in an advanced technology environment. Candidate must be able to develop and drive a medical regulatory environment for class I and class II medical devices via procedures, product development, submissions and interaction with development teams and regulatory bodies. Candidate will also need to provide regulatory guidance and expertise for consumer devices as needed.
- Work with Senior Management to develop class I and class II regulatory strategies for current and new market entries (e.g. US, EU, APAC, LATAM, etc.)
- Work with New Product Quality and Quality Systems to provide guidance and support on Healthcare and Consumer development
- Support design control process to ensure regulatory documentation is adequate for required submissions.
- Create and submit regulatory submissions (e.g. 510k, IDE, Technical Files, etc)
- Review and approve all device labeling, IFUs and packaging
- Implement and improve regulatory related QMS procedures.
- Provide guidance and support on interaction with governmental agencies or regulatory bodies (e.g. FDA, CPSC, Notified Bodies, etc.)
- Motivate, inspire, and improve regulatory compliance culture across the organization
- Build effective and sustainable cross functional relationships
- Implement and maintain all regulatory registrations and submissions required for market entry.
- Support day to day regulatory and QMS operations
- Support complaint handling process with regulatory guidance
- Oversee the IRB interaction for any clinical research.
- Support internal/external audits and implement corrective/preventive action as needed
- Work with Human Resources, provide comprehensive regulatory training to all employees
- Bachelor’s degree or equivalent
- 7+ years of experience in working in regulatory environment for
- Medical devices (e.g., Part 803 MDRs, Part 806 Corrections/Removals, Part 807 Establishment Registration and Device Listing, , 510ks, IDEs)
- Consumer products (e.g., CPSC)
- RAC certified is a plus
- Proficiency with MS and Google software applications.
- Demonstrated ability to write technical documents (e.g., QMS processes, regulatory submissions)
- Strong interpersonal, communication, analytical and complex problem solving skills.
- The ability to develop partnerships and influence
- Ability to work independently and has strong team building skills.
- An understanding of the principles of proper configuration management and document control.
- Ability to understand technical product and be able to effectively communicate details to regulatory bodies as needed
- Ability to work in fast paced environment
All your information will be kept confidential according to Equal Employment Opportunities guidelines.