Specialist 4, Regulatory Affairs

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Irvine (CA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in Irvine, CA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategy, submissions, and global registrations for medical devices. You will partner with product teams to ensure timely regulatory milestones and compliance for new and existing products.

Ideal candidates have 6+ years in medical device regulatory affairs, strong communication skills, and experience with FDA and international submissions. Significant travel may be required.

Qualifications

• Bachelor's degree required; advanced degree highly desired; RAC certification a plus.

Responsibilities

• Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence.
• Define, gather and assemble information necessary for submissions in accordance with regulations and guidelines.
• Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries.
• Communicate with FDA and Notified Body reviewers to identify pre-submission requirements and align submission strategy.
• Lead the submission of licenses and authorizations for existing products and support international registrations.
• Guide conformance with regulations in cross-functional projects and labeling development.

Skills

Regulatory strategy

Regulatory submissions

FDA interactions

Cross-functional collaboration

Education

Bachelor's Degree

Advanced Degree

RAC certification

Job description

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: Irvine, California, United States of America, Irving, Texas, United States of America

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 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.

Key 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

Qualifications / Requirements

Education Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field. RAC certification a plus.

Experience and Skills 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 This position will require up to 15-20% travel

Equal Opportunity Statement

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Compensation and Benefits

The anticipated base pay range for this position is : $109,000.00 - $174,800.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, 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.

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year
• Sick time - 48 hours per calendar year; for employees who reside in the State of Colorado
• Sick time - 56 hours per calendar year; for employees who reside in the State of Washington
• 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
• Bereavement Leave – 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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 https://www.jnj.com/.