Senior Director Regulatory Affairs-Biosurgery

Overview

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 Med Tech, we innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at

Job Function
:
Regulatory Affairs Group

Job Sub Function
:
Regulatory Affairs

Job Category
:
People Leader

All Job Posting Locations
:
Raritan, New Jersey, United States of America

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Director, Regulatory Affairs-Biosurgery to be in Raritan, NJ with a minimum of 25% domestic and international travel.

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

• Define and execute global regulatory strategy for biosurgery products (devices, combination products, biologics-linked devices) to maximize speed-to-market and lifecycle management.
• Oversee planning, preparation, and submission of regulatory dossiers (e.g., PMA/510(k)/BLAs in the U.S., CE/UKCA in Europe, PMA equivalents internationally, IDE/Clinical submissions as needed).
• Lead regulatory risk assessment, gap analyses, and contingency planning for development programs and product lifecycle processes.
• Ensure timely, compliant submissions and interactions with regulatory authorities; manage responses and negotiations to secure approvals and clearances.
• Establishes relationships and negotiates with government officials to obtain clearance or approval to market, and work to influence and shape the stakeholders in the external environment.
• Build, mentor, and manage a high-performing regulatory affairs team; cultivate strong partnerships with Clinical-Medical, Quality, Legal, Global Strategic Marketing and Supply Chain teams.
• Represent regulatory affairs in operating committees, platform leadership teams and at external meetings with regulators and industry groups.
• Provide strategic direction and leadership in the development of a comprehensive regulatory plan aligned with business objectives, and provide direction to the functional groups responsible for obtaining global regulatory approvals.
• Develop and oversee department budget.

Education
:

• A minimum of a Bachelor's Degree is required; an advanced degree is preferred.

Experience And Skills

Required

• A minimum of 15 years of experience within a regulated industry is required.
• Experience managing people leaders.

Preferred

• Minimum 3 years of Director-level regulatory leadership;
  Senior Director experience preferred.
• Prior hands-on biosurgery submission experience with a track record of obtaining approvals across multiple regions (US, Europe, UK, ASIA).

Other

• English fluency required.
• 25% domestic and international travel.

For more information on how we support the whole health of our employees, please visit

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 inclusive interview process. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via ; internal employees contact AskGS to be directed to your accommodation resource.

Required Skills

Preferred Skills
:
Business Writing, Cross-Functional Work, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Compliance, Risk Management, Strategic Thinking

The anticipated base pay range for this position is : $196,000-$338,106

Additional Description For Pay…