Senior Regulatory Affairs Program Lead

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.

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 for 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 technical documentation. The Senior Regulatory Affairs Specialist helps to define data and information needed for regulatory approvals in conjunction with cross-functional 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 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.
• 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.
• 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 Irving, TX and requires minimal travel (10% - 15%).

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking