Regulatory Affairs Specialist
Location:
Milpitas , California
Posted:
April 02, 2017
Reference:
AMO30037234-en-us

Johnson & Johnson Vision, part of the Johnson & Johnson Family of Companies, is currently recruiting for a Regulatory Affairs Specialist in Milpitas, California.

 

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

 

The function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and exercise influence generally at the middle management level.  The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide. 

 

The Regulatory Affairs Specialist will:

 
  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
  • Determine trade issues to anticipate regulatory obstacles
  • Determine and communicate submission and approval requirements
  • Participate in risk-benefit analysis for regulatory compliance
  • Monitor applications under regulatory review
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Assist in preparation and review of regulatory submission to authorities
  • Maintain annual licenses, registrations, listings and patent information
  • Assist compliance with product post marketing approval requirements

Qualifications
Required
  • Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
  • 2-3 years’ experience in a regulated industry (e.g., medical products, nutritional's). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

Primary Location
United States-California-Milpitas
Organization
Abbott Medical Optics, Inc. (6233)
Job Function
Regulatory Affairs
Requisition ID
AMO30037234

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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