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Regulatory Compliance Specialist

2 months ago

Lake Forest, California, United States Astrix Inc Full time

Company Overview:

Astrix Inc. is a prominent leader in the manufacturing of innovative eye care solutions and medical devices. We are currently seeking a Regulatory Affairs Specialist to enhance our dedicated team.

Position Overview:

As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with global regulations while supporting our product registration efforts.

Location: Remote

Compensation: Competitive hourly rate

Key Responsibilities:

  • Collaborate with international partners to facilitate global registration initiatives.
  • Engage closely with internal stakeholders to align regulatory strategies with business goals.
  • Manage inquiries from various regions, providing timely responses and necessary documentation.
  • Prepare essential documentation and coordinate legalizations as per country-specific regulations.
  • Support communication efforts with both domestic and international regulatory teams.
  • Ensure adherence to global regulatory standards and internal policies.
  • Deliver high-quality regulatory support for assigned projects and products.
  • Draft clear and comprehensive documents to aid in registration renewals and licensing.
  • Consolidate and follow up on change assessments for global regulatory strategies.
  • Review and validate labeling to ensure content accuracy.
  • Maintain up-to-date knowledge of international medical device regulations, including facility registration and product listing.
  • Keep thorough documentation and historical records for all regulatory submissions.
  • Notarize regulatory documents as required, with a willingness to obtain a notary license.

Qualifications:

  • Bachelor's Degree or equivalent experience in a related field.
  • Proficient in reading, writing, and communicating in English.
  • Minimum of 2 years of relevant experience in regulatory affairs.
  • Standard work hours are Monday through Friday, 8 AM to 5 PM.
  • Minimal travel may be required.