Johnson & Johnson MedTech · 1 day ago
Director, Regulatory Affairs (Monarch Surgical Robotics) - MedTech Surgery
Santa Clara, CA
Full-time
Hybrid
Director/Executive
$189K/yr - $325K/yr
7+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to developing advanced surgical technologies. The Director of Regulatory Affairs will establish regulatory strategies for the Monarch robotics platform, ensuring compliance and facilitating the approval process for new and modified products.
Hospital & Health Care
Responsibilities
Develop global regulatory strategies to gain earliest possible, least burdensome regulatory approval in US and other international markets for new or modified products
Ensures required content for regulatory submissions are defined and oversee the preparation of submissions
Develop and manage submission timelines & resources to support regulatory milestones
Represent Regulatory Affairs on the Platform Leadership Team
Build and effectively lead high-performing Regulatory team
Monitor and provide management with impact of changes in the Regulatory environment
Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions in coordination with management
Ensures change control documents are reviewed and regulatory impact for external and internal documents are ascertained and rationales to file documentation for modifications to devices are established
Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies
Provide review and approval of all external facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations
Participate in FDA, notified body and other regulatory body inspections
Establish processes and systems to ensure efficient and effective RA operations
Qualification
Required
Minimum of a Bachelor's Degree in a scientific or technical discipline required; Advanced Degree strongly preferred
Minimum of 7-10+ years of experience in Medical Device Regulatory Affairs with specific experience with preparing domestic and international regulatory submissions required
Robotics experience highly desired
3-5+ years of managerial experience (direct reports) required
SaMD (Software as a Medical Device) regulatory experience is required
Shape and contributes ideas that challenge thinking, proposes and tries new novel approaches
Experience in Q-sub, pre-submission negotiation process
Working knowledge of IEC 60601-series standards
Prior experience with electro-mechanical software-driven devices
Superior written and verbal communication and presentation skills
Track record of successfully obtaining market clearance and/or approvals domestic and international
Ability to translate and simplify technical content or regulations and communicate to stakeholders
An approachable individual who provides a high level of teamwork and cross-functional collaboration
Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks
Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820
Up to 20% travel may be required
Preferred
Business Writing
Collaborating
Continuous Improvement
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
Strategic Thinking
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s 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 Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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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