Manager Regulatory Affairs
Location:
Milpitas , California
Posted:
April 02, 2017
Reference:
AMO30037051-en-us

Johnson & Johnson Vision, part of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager Regulatory Affairs, located 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 Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.  Additionally, the individual may develop and supervise regulatory professionals.  The individual has department/group/site level influence and is generally recognized as an expert and resource within the department.  The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance.  The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

 
The Manager Regulatory Affairs will:
 
  • Identify need for new regulatory policies, processes and SOPs and approve them
  • Provide strategic guidance for product development and planning throughout the product lifecycle
  • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related team
  • Recruit, develop and manage regulatory professionals
  • Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing changes
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Communicate application progress to internal stakeholders
    Monitor and submit applicable reports and responses to regulatory authorities
  • Manage pre-approval compliance activities
  • Formulate company procedures to respond to regulatory authority queries
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
  • Ensure external communications meet regulations
  • Review and approve labeling to ensure compliance
  • Develop, implement and manage SOPs and systems to track and manage product associated events
  • Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
  • Report adverse events to regulatory agencies and internal stakeholders
  • Represent regulatory affairs in product recall and recall communication process


Qualifications
Required
  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.  M.S. in a technical area or M.B.A. is preferred.  A Ph.D. in a technical area or law is helpful 
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
  • 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals)
  • 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas

Primary Location
United States-California-Milpitas
Organization
Abbott Medical Optics, Inc. (6233)
Job Function
Regulatory Affairs
Requisition ID
AMO30037051

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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