Senior Regulatory Affairs Program Lead - Mentor Worldwide, LLC

Johnson & Johnson Innovative Medicine•Irving, TX

2d•Hybrid

About The Position

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. 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 Mentor business unit. This role will be based in Irving, TX and will work a Flex/Hybrid schedule with 3 days per week on-site. There is no remote option. No relocation assistance is provided. Mentor is a leading brand of breast implants and tissue expanders in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical medical procedures that allow breast surgery patients to improve their quality of life. We focus on two strategic areas: breast reconstruction and breast augmentation.

Requirements

Minimum of a Bachelor’s Degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration is required.
At least 6+ years of regulatory affairs or related/equivalent experience within a highly regulated industry.
Experience interacting with regulatory agency personnel, to resolve regulatory matters.
Must have excellent written, verbal communication and presentation skills.

Nice To Haves

RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society desirable.
Previous experience with medical devices strongly preferred.
Experience working with professional and trade associations preferred.
Project Management skills desired.
Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as European Union Technical Documents (CE Mark), and other geographies a plus.

Responsibilities

Strategic partner with key cross functional colleagues to develop and execute global regulatory strategies and timelines for existing products to assure on-time regulatory approval/clearance and post-marketing activities while mitigating supply disruptions.
Reviews product design, labeling, and manufacturing changes to existing products to assess the impact to safety and efficacy as needed.
Ensures compliance with regulatory agency regulations and interpretations.
Defines, gathers and assembles data necessary for submissions in accordance with regulations and relevant guidelines while partnering with other functions.
Prepares responses to regulatory agencies' questions and other correspondence.
Provides regulatory advice to project teams and recommends solutions to complex problems in which data analysis requires an evaluation of intangible variables.
Develops labeling specifications and approves proposed labeling and packaging, after evaluating conformance to regulations
Provide Regulatory Affairs support during internal and external audits
Plans schedules for regulatory deliverables on a project and monitors project through completion
Assists in the development of best practices for Regulatory Affairs processes.
Represents Regulatory Affairs on cross-functional project teams
Clearly and timely communicates compliance issues to Regulatory Management and business leaders that could affect registration or regulatory compliance.
Ensure company policies, procedures and practices are compliant with appropriate regulatory requirements.