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Sr Regulatory Affairs Specialist

Company: Disability Solutions
Location: Irvine
Posted on: May 12, 2024

Job Description:

Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Johnson & Johnson Vision Care, Inc. (JJVCI), a member of the Johnson & Johnson Family of Companies, is currently seeking a Senior Regulatory Affairs Specialist to be based in Jacksonville, FL or Irvine, CA . JJVCI 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 and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. The Senior RA Specialist will manage international registration/submission activities for Johnson & Johnson Vision (JJV) including Johnson & Johnson Vision Care, Inc. (JJVC) and Johnson & Johnson Surgical Vision, Inc. (JJSV) including but not limited to, management of China registration for New Product Introductions (NPI) and Life-cycle Management (LCM) changes such as post- market changes, renewals, and discontinuations. This individual will drive discussions and collaborate with the China RA teams, Platform RA teams, and cross-functional teams as needed to proactively provide the necessary information and documentation to accelerate submissions. This individual may also support international registrations for Europe, Middle East, Africa (EMEA), Latin America and Asia Pacific as needed This individual will drive the self-testing discussions from a regulatory perspective, collaborating with China RA and Global to leverage the self-testing option where possible and to ensure we have a well-defined and consistent process across JJV. This individual will lead the discussions and cross-functional reviews of the China Product Technical Requirements (PTR) documents, testing questions and HA deficiencies. This individual will be responsible for providing regular status reports/updates on JJV China initiatives and submissions. This individual will lead the reviews and global assessments for new or revised requirements (e.g. regulations, guidance documents, standards, etc.). Responsibilities: --- Drives discussions with China RA and Platform RA to proactively prepare for upcoming NPI submissions to accelerate the health authority (HA) submission where possible. --- Execute/fulfills submission requirements for NPI and LCM submission requests. --- Drives discussions/collaboration with China RA and cross-functional team members to review/update the PTR documents and leverage self-testing, address testing questions and HA deficiencies where and when possible. --- Drives discussions with Global / Platform RA, Research & Development, Clinical and relevant and cross-functional partners to ensure China requirements are understood and built in early in the product development process where/when possible. --- Drives required discussions/collaboration for China specific requirements to assess new or revised health authority requirements (e.g. regulations, standards, etc.) --- Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations. --- Partners with other functions and Subject Matter Experts (SME's) to obtain information and/or data required for regulatory submissions. --- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. --- Represents Regulatory Affairs on cross-functional project teams. --- Adheres to environmental policy and procedures and supports department environmental objectives. --- Responsible for communicating business related issues or opportunities to management.

Keywords: Disability Solutions, Irvine , Sr Regulatory Affairs Specialist, Other , Irvine, California

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