Sr Regulatory Affairs Specialist - 2406185151W

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 https://www.jnj.com/.

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 or Milpitas, 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.

Qualifications

• A minimum of a Bachelor’s degree with at least 4 years of working experience within a regulated environment

• Medical Device Regulatory environment preferred

• Excellent written, verbal communication and presentation skills is required.

• A scientific and technical understanding of medical device regulations within scope of responsibility to provide strategic guidance and regulatory input for international submissions is required.

• The ability to manage large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives is required.

• The ability to demonstrate the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives is required.

• Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions is required.

• Knowledge of and experience with China regulations/requirements and submissions is preferred.

• Knowledge of MDR, US FDA requirements / guidelines is preferred.

• Previous experience working with cross functional teams within a matrix environment is preferred.

• Fluency in Mandarin is preferred.

This job posting is anticipated to close on 6/7/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base salary for this position is $88,000 to $141,450.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location NA-US-California-Irvine

Other Locations NA-US-Florida-Jacksonville, NA-US-California-Milpitas

Organization Johnson & Johnson Surgical Vision, Inc (6234)

Job Function Regulatory Affairs

Req ID: 2406185151W