Regulatory Affairs Manager

300 - RA & QA · Aliso Viejo, California
Department 300 - RA & QA
Employment Type Full-Time
Minimum Experience Experienced

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Regulatory Affairs Manager responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products.  In this role, you will prepare product submissions, handle license renewals, and provide periodic updates and registrations to regulatory agencies. 

You will:

  • Actively participate in the evaluation for regulatory compliance, documents, products, and process and test method changes
  • Review labeling and labels for compliance to regulatory submissions
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners
  • Compile materials for license renewals, updates, and registrations in a timely manner
  • Support product registration and post-approval activities, as assigned
  • Maintain regulatory files/databases in proper order
  • Establish and maintain system for tracking document changes submitted to agencies and partners
  • Provide regulatory reviews of customer complaints, define regulatory reportability, and complete reports as required
  • Participate in research of regulatory issues and disseminate regulatory information to Production, QA, QC, and R&D departments and senior management as required
  • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process
  • Complete submissions to FDA, EU, and other regulatory agencies
  • Create and maintain product EU technical files
  • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws

You need:

  • BS/BA degree
  • 5+ years in medical device regulatory affairs, preferably in Class II orthopedic devices
  • Understanding of current FDA and International regulations, guidance and standards applicable to medical device products
  • Ability to maintain corporate confidentiality at all times
  • International experience required
  • Experience with EU Class I devices and FDA Class II devices is preferred
  • Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
  • Excellent written and verbal communication skills
  • Results-oriented with appropriate follow-up to issues
  • Ability to work as a collaborative team member as well as independently supervision
  • Excellent attention to detail, producing high quality output
  • Flexibility and strong organizational skills with ability to prioritize multiple tasks
  • Strong interpersonal relationship skills including negotiating and relationship management
  • Ability to apply sound judgment when making decisions and communicating with internal and external customers

We offer:

  • Innovative products
  • Awesome benefits
  • Great coworkers
  • An evolving, engaging culture and work place

It is an exciting time at OrthAlign - make your next career move with us!

Please note we are unable to offer any type of sponsorship at this time.

Thank You

Your application was submitted successfully.

  • Location
    Aliso Viejo, California
  • Department
    300 - RA & QA
  • Employment Type
  • Minimum Experience