Regulatory Affairs Leadership Development Program (RA Specialist II) - United States

Job description

Johnson & Johnson's Medical Devices Regulatory Affairs Center of Excellence is currently recruiting a Regulatory Affairs Specialist II to join the AcceleRAte Regulatory Affairs Leadership Development program (RALDP). The position is based at a J&J Medical Devices facility in one of the following locations: Somerville, NJ; West Chester, PA; Raynham, MA; Cincinnati, OH; Warsaw, IN or Irvine, CA.

Caring for the world one person at a time has inspired and united the people of Johnson & Johnson for 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. We have more than 275 operating companies in more than 60 countries, with more than 128,700 employees.

The Medical Devices franchises comprise the world's largest medical technology business, providing doctors, nurses, and hospitals with the technologies they need to restore the joys of life to people who suffer from some of the world's most pervasive and chronic conditions.

The Global Surgery, Global Orthopedics, Cardiovascular and Specialty Solutions, and Diabetes Care Regulatory Affairs Centers of Excellence has recently integrated to support all operating companies under Johnson & Johnson's Medical Devices Division.

The RALDP is a two year and four month program designed to develop future business leaders throughout the MD Regulatory organization. The program focuses on a broad range of medical device technologies, new product development and life cycle management, policy management, and submissions. At the heart of the program are two 8-month and one 12-month rotational assignments. Rotations will vary based on location and business need and will be determined by commutable operating company locations. Classroom and online training in leadership development and other professional skills are included.

Positions at this level are typically mid-level professionals who have the skill and experience to complete assignments under general supervision. Job responsibilities include:

·  Providing assistance in the preparation of US and International regulatory submissions, including, but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files.
·  Coordinating and submitting licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
·  Preparing regulatory labeling requirements specifications for new and modified products, and reviewing product labeling to ensure compliance.
·  Participating and providing support to product development teams on both US and international issues.
·  Reviewing technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments.
·  Responding to product information requests.
·  Researching and collecting information and data to support periodic reports to regulatory agencies.
·  Providing Regulatory Affairs support during internal and external audits.
·  Assisting in the development of best practices for Regulatory Affairs processes.
·  Representing Regulatory Affairs on cross-functional project teams.
This position may require up to 15% domestic/international travel.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Desired profile

·  Master's degree in regulatory sciences, life sciences, engineering, or a related discipline is required. (A maximum time of 1 year from graduation.)
·  0-2 years working experience in regulatory affairs, life sciences, engineering, or related field.
·  Previous pharmaceutical, Medical Device, or other regulated industry experience is preferred. R&D, Clinical/Medical experience is preferred.
·  Demonstrated leadership ability required.
·  Excellent writing, communication, organizational, and interpersonal skills are required.
·  Experience reviewing documents for assessment of completeness and compliance with regulatory requirements is preferred.
·  Demonstrated ability to effectively coordinate projects and collaborate productively with both individuals and departments is required.
·  Experience managing and maintaining documentation for training, operating procedures and/or quality requirements is preferred.
·  Proficiency in the Microsoft Office suite of products is required.
·  Audit experience is an asset.
·  GXP training is an asset.
·  Up to approximately 10% domestic travel may be required. Permanent US work authorization is required.
Johnson & Johnson Companies are equal opportunity employers.