Senior Regulatory Affairs Program Lead - Mentor, LLC

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

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Irving, Texas, United States of America

Job Description:

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to be based in Irving, TX. This role will support our Mentor business unit.

Purpose: The Senior Regulatory Affairs Program Lead is responsible for partnering with R&D, Life Cycle Management (LCM), Supply Chain, Quality Engineering, Global Strategic Marketing, and other key cross-functional leaders to develop and execute robust global regulatory strategies focused primarily on LCM guidance and projects for both of our manufacturing facilities. The successful candidate will provide regulatory guidance to product development teams in strategic planning and related submissions to support optimal timelines for modified product launches, cost savings and other business initiatives. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory approvals in conjunction with cross-functional LCM teams. The role assists in the development of best practices for Regulatory Affairs processes.

You will be responsible for:

• 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.

Qualifications / Requirements:

• Minimum of a Bachelor's Degree required, Advanced Degree strongly preferred. Science, biomedical engineering, medical / scientific writing, public health administration area desired.
• At least 6+ years (4+ with Advanced Degree) of regulatory affairs or related experience.
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society highly desired.
• Previous experience with medical devices strongly preferred.
• Experience working with professional and trade associations.
• Project Management skills.
• Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as European Union Technical Documents (CE Mark), and other geographies strongly preferred.
• Experience interacting with regulatory agency personnel, to resolve regulatory matters.
• Must have excellent written, verbal communication and presentation skills
• This position is located at our manufacturing facility in either Irving, TX and requires minimal travel.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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