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Regulatory Affairs Specialist II

Johnson & Johnson

Cutting-edge science, digital technology, and new ways of thinking are improving how people are cared for around the world, and Johnson & Johnson is at the forefront.

Johnson & Johnson Vision Care, Inc., a member of Johnson & Johnson Family of Companies is recruiting for a Regulatory Affairs Specialist II located in Jacksonville, FL.

Johnson & Johnson Vision Care, Inc. 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.

This role will be responsible for registration activities including the generation of and/or confirmation of submission documentation related to new product development, new product introduction, renewals, post-approval changes, discontinuations, etc. for the Asia Pacific (ASPAC), Japan, Latin America (LATAM) and Europe, Middle East, and Africa (EMEA).

This person will work closely with the regional teams and the Regulatory Operations team to ensure a clear understanding of Health Authority (HA) requirements and ensure high-quality documentation is dispatched to the local teams for timely HA submissions. This role will ensure ongoing and frequent communication with regional teams/partners. This individual will ensure any new external requirements (e.g. regulations, standards, etc.) are identified and assessed in a timely manner as well as assist with any other sub-functional areas within the department as needed.

This person will flex as needed to support Regulatory Operations activities such as prioritizing registration requests, formatting/publishing submission documents, acquiring the vital approvals, dispatching the submission documents, etc.

Duties and Responsibilities:

  • Generate and/or confirm the content for global submissions to ensure accurate and up-to-date information is being provided to Health Authorities globally in compliance with local regulations
  • Research, collect data, and respond to requests from Health Authorities and/or distributors to prepare and submit documentation for marketing approvals, as well as provide routine regulatory information to associates and affiliates
  • Use various tools and systems applied by RA (e.g., Teamcenter, StartingPoint, MDRIM, etc.)
  • Provide solutions to a variety of problems of moderate scope and complexity
  • Assist in the development of standard methodologies for Regulatory Affairs processes
  • Provides support to projects of medium complexity and ensures timely and effective decisions based on available information to complete project deliverables. Ability to make decisions with mentorship
  • Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions is required

Qualifications

Qualifications:

  • A minimum of a bachelor’s degree with at least 2 years of working experience within a regulated environment or equivalent, preferably focused on medical devices.
  • Excellent written and verbal communication is required.
  • The following skills are required: attention to detail, ability to handle multiple priorities at once, prioritization, quick response time, collaborative, time management
  • Experience with medical device regulations and submissions is preferred.
  • Based in Jacksonville, Florida and may require up to 10% domestic and/or international travel.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

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
United States-Florida-Jacksonville-7500 Centurion Parkway
Organization
Johnson & Johnson Vision Care, Inc. (6094)
Job Function
Regulatory Affairs
Requisition ID
2206041955W

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Regulatory Affairs Specialist II

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Johnson & Johnson

Cutting-edge science, digital technology, and new ways of thinking are improving how people are cared for around the world, and Johnson & Johnson is at the forefront.

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