Johnson & Johnson MedTech · 7 hours ago
Senior Director Regulatory Affairs-Biosurgery
Raritan, NJ
Full-time
Onsite
Director/Executive
$196K/yr - $338K/yr
15+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, aiming to improve health outcomes through advanced medical solutions. They are seeking a Senior Director of Regulatory Affairs-Biosurgery to define and execute regulatory strategies for biosurgery products, ensuring compliance and accelerating market access while leading a high-performing team.
Hospital & Health Care
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
Qualification
Required
A minimum of a Bachelor's Degree is required, an advanced degree is preferred
A minimum of 15 years of experience within a regulated industry is required
Experience managing people leaders
English fluency required
25% domestic and international travel
Preferred
Minimum 3 years of Director-level regulatory leadership; Senior Director experience preferred
Prior hands-on biosurgery submission experience biosurgery submissions with a track record of obtaining approvals across multiple regions (US, Europe, UK, ASIA)
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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