Regulatory Affairs Specialist 1

24 Apr, 2022

Jobs

Regulatory Affairs Specialist 1

Johnson & Johnson
Raynham, MA

Job Description

DePuy Synthes, part of the Johnson & Johnson Medical Device Companies, is recruiting for a Regulatory Affairs Specialist I – Spine in Raynham, MA.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Key Responsibilities:

  • Provides independent regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support efficient timelines for new/modified product launches in the global market
  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files.
  • Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
  • Defines data and information needed for regulatory approvals.
  • Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Provide Regulatory Affairs support during internal and external audits.
  • Plans schedules for the delivery of supporting documentation required for regulatory submissions on a project and monitors project through completion.
  • Assists in the development of improved and efficient processes practices for Regulatory Affairs processes.
  • Represents Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams in both US and international issues.
  • Partners with other functions to define and generate data to assist with regulatory submissions.
  • Review and provide regulatory authorization for Engineering Change Orders (ECOs).
  • Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.

Qualifications

Education:

  • A minimum of a bachelor’s degree is required, advanced degree(s) is preferred.
  • Educational background in science, engineering, business, or legal subject areas preferred.

Experience And Skills:

  • Motivation and intellectual capacity to identify, read, understand, and address global medical device regulations are required.
  • Practical knowledge in the medical device or another regulated industry is preferred.
  • Knowledge of US and European regulatory processes is preferred.
  • Experience in the preparation and submission of US Regulatory files (510(k)s, PMAs), as well as European technical files and design dossiers, is preferred.
  • Must have excellent written, verbal communication, and presentation skills.

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.

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Job posted: 2022-04-24