Coordinator - Regulatory Affairs


Johnson & Johnson Surgical Vision (JJSV) is recruiting for Coordinator, Regulatory Affairs in Santa Ana, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry. The primary responsibility of this individual is directly Responsible for managing routine regulatory procedures, final submission reviews, updating department metrics/reports, tracking and archiving of documents/files that are submitted to various regulatory agencies. Coordinating audit support activities as well as general administrative duties as assigned. Adheres to environmental policy, procedures, and supports department environmental objectives. Engages in Credo-based decision-making. You, the Coordinator, Regulatory Affairs, will:
  • Process owner for managing routine regulatory procedures (e.g. tracking of timely technical file updates, periodic and annual reports, and other conditions of approval).
  • Prioritizes daily tasks associated with finalizing regulatory submissions.
  • Reviews submission outlines and assembled submissions for completeness and accuracy.
  • Conducts review of somewhat complex submissions for adherence to established quality standards, department SOPs, and submission checklists.
  • Identifies documents and files that need to be archived, and maintains regulatory department files.
  • Tracks and follows up on submissions, interfaces with document control, and ensures timely filing of regulatory documents.
  • Provides periodic updates on submission progress to department staff.
  • Reviews and distributes updates on submission standards, quality and formatting rules, guidelines and acceptance criteria.
  • Ensures changes in regulatory requirements are communicated to cross-functional partners.
  • Coordinates RA audit support needs with cross-functional teams.
  • Maintains lists of technical files, product approvals and other data for audit readiness.
  • Gathers and maintains department metrics, updates product approval database, and creates accurate reports from complex data inputs.
  • Prepares briefing documents for meetings with regulatory authorities, and coordinates meeting arrangements.
  • Performs general administrative duties (e.g. P.O. generation) as assigned.

Qualifications
  • Associates degree in technical field required
  • Bachelors’ Degree preferred
  • A minimum of 4 years of related experience is required.
  • Excellent written and oral communication skills.
  • Good analytical thinking, problem solving and investigative skills.
  • Proficiency in Microsoft Office and all related applications
  • Notary Public certification desirable
  • Up to 10% travel
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location
United States-California-Santa Ana
Organization
AMO US Holdings, Inc.. (6234)
Job Function
Regulatory Compliance
Requisition ID
1309180511
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