Senior Regulatory Affairs Program Lead (Monarch) - MedTech Surgery

Johnson & Johnson • Santa Clara, CA

18h • Hybrid

About The Position

The Senior Regulatory Affairs Program Lead provides regulatory guidance to project teams in strategic planning and related submissions to support the Monarch Platform under minimal supervision. The individual is responsible for developing and executing regulatory strategies to support new, modified, and currently marketed medical devices. This includes the preparation of regulatory documentation for submissions to regulatory health authorities (i.e., European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures, and systems.

Requirements

• Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
• Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree).
• Experience with Class II medical device regulatory product submissions required.
• Previous experience with health authority meetings/interactions required.
• A demonstrated track record of developing and driving implementation of regulatory strategies.
• Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML.
• Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601).
• Excellent communication skills for effective collaboration with cross-functional partners.
• Strong attention to detail.
• Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.
• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
• Advanced analytical and problem-solving skills.
• High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
• Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.

Responsibilities

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.
• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information required to obtain global market access.
• Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s).
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
• Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission.
• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development and enhancement of Regulatory Affairs processes.

Benefits

• 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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior