Specialist 4, Regulatory Affairs

Johnson & Johnson•Irvine, CA

6d•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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Specialist 4, Regulatory Affairs position. The Sr. Regulatory Affairs Program Lead has end to end responsibility for the life cycle maintenance and new product development launches within the Mentor 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 product launches. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, supports the creation of international registrations, and dossiers. 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.

Requirements

Minimum of a Bachelor's Degree required
Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree), or a combination of relevant experience.
Experience with medical device regulatory submissions for medium to high-risk devices is required.
A demonstrated track record of developing and driving implementation of regulatory strategies.
Working knowledge of how global regulations impact product registration.
Excellent verbal and written communication skills for effective collaboration with cross-functional partners.
Corresponding and collaborating with colleagues globally for strategic contribution and achievement of regulatory milestones.
Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
Strong attention to detail.
Advanced analytical and problem-solving skills.
High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
Strong learning and presentation skills for complex technology to communicate in a clear, concise, and comprehensive fashion.
Consistently manages large, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.
Connect by encouraging and supporting internal collaboration across levels, creating effective solutions.
Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
Previous experience with health authority meetings/interactions

Nice To Haves

Advanced Degree highly desired
desired areas of study include Science, Engineering, or related field.
RAC certification a plus.

Responsibilities

Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data
Define, gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals
Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed
Provide solutions to complex problems in which data analysis requires an evaluation of intangible variables
Lead the submission of licenses and authorizations for the maintenance of existing products, supporting international registrations, and dossiers
Guide conformance with applicable regulations in cross functional projects, product development, support of claims and label content
Collaborate in the development and approval of labeling, 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 and systems
Partners with other functions to define and obtain data to assist with regulatory submissions
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.