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Direct hire opportunities (Mgr & Specialist) in Regulatory Affairs

Company Name: STAAR Surgical
Location: Monrovia, CA
Job Type: Regular Full Time
Contact Name: Jolson Pham
Email: Please send inquiries and resumes to This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: competitive

Job Description

STAAR Surgical Company (NASDAQ: STAA), founded in 1982 and is headquartered in Monrovia, California, is a global class III medical device developer and  manufacturer of implantable lenses and its companion delivery systems for the eye. The company offers EVO and  Visian implantable collamer lenses (ICLs) to treat visual disorders, such as myopia, hyperopia, astigmatism, and presbyopia; and Hyperopic ICL, which treats far-sightedness.  We also have R&D location in Tustin. 

We are looking for a Manager of Regulatory Affairs and a Regulatory Affairs Specialist to work at our Monrovia facility.  

  • Prepares and manages all aspects of all ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports.
  • Plans and prepares complex regulatory documents for global registrations.
  • Ensures effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets.
  • Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
  • Reviews proposed labeling and promotional material to ensure that the intended use and claims are supported for use and domestic and international regulations are met.
  • Provides strategic direction and advice to project team regarding regulatory pathways and timelines for new and changed products/processes.
  • Establishes, organizes and maintains regulatory records.
  • Obtains and manages foreign registrations; partner with appropriate representatives to locally confirm and file foreign regulatory requirements. Ensures compliance with global regulations and regulatory agencies.



Job Requirements 

EDUCATION

  • Bachelor of Science degree in a scientific related field. Advanced degree preferred. 

EXPERIENCE

  • Minimum 3 to 5 year experience for Manager level and 1-3 years for Specialist level. 

SKILLS

  • Thorough understanding of FDA and international regulations (Chinese FDA a plus).
  • Strong working knowledge of medical devices regulations and terminologies.
  • Excellent written and oral communication, and technical writing and editing skills.
  • Ability to write clear, understandable technical documentation.
  • Skilled at analyzing and summarizing data.
  • Proficient with Microsoft Office.
  • Ability to manage and prioritize multiple projects.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • Ability to work independently with minimal supervision.
  • Extreme attention to detail.
  • Ability to work in a team setting.