Senior Regulatory Affairs Program Lead (Wound Closure & Healing) - MedTech Surgery

At 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Remote (US)

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Wound Closure and Healing group. Preference will be given to candidates located within a commutable distance of Raritan, NJ however remote work options will be considered on a case by case basis and if approved by the company.

Purpose: The Senior RA Program Lead has end to end responsibility for the life cycle maintenance and new product development launches within the Wound Closure and Healing portfolio. The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified global product launches. Under little to no supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers to support new, modified and currently marketed medical devices. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Senior RA Program Lead helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role assists in the identification and development of best practices for Regulatory Affairs processes.

You will be responsible for:

· Represent Regulatory Affairs on cross functional teams and serve as a regulatory SME on projects, including partnering with other functions to define and obtain data to assist with regulatory submissions.

· Provide input and guidance during New Product Development and Lifecycle Change Management projects, including regulatory strategy and supporting evidence including clinical data.

· Prepare expert responses to regulatory agencies' questions and other correspondence.

· Prepare and submits regulatory information required to obtain timely US and EU market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and EU MDR submissions.

· Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.

· Collaborate in the development and approval of labeling and claims development.

· Provide Regulatory Affairs support during internal and external audits.

· Plan schedules for regulatory deliverables on a project and monitors project through completion.

· Assist in the development of best practices for Regulatory Affairs processes. Provide solutions to complex problems in which data analysis requires an evaluation of intangible variables.

· Applies expert knowledge of guidances, regulations, and standards relevant to product portfolio.

Functional and Technical Competencies:

· Leverages deep scientific and technical understanding of regulated products within the scope of responsibility to provide strategic regulatory guidance and support for product development and lifecycle management.

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