Senior Director Regulatory Affairs-Biosurgery

Raritan, NJ - USA

Monthly Salary: $ 196000 - 338106

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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

Job Description:

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 were 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 thats 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 worlds 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 Responsibilities:

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.
Provides strategic direction and leadership in the development of comprehensive regulatory plan that is aligned with business objectives as well as provide strategic direction and leadership to the functional groups responsible for obtaining regulatory approvals globally
Developing and overseeing department budget.

Qualifications

Education:

A minimum of a Bachelors 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
Preferred: Prior hands-on biosurgery submission experience biosurgery submissions 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 throughout their wellness career and life journey 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 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 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 :

$196000-$338106

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Exec