Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Regulatory Affairs Program Lead, NeuWave located in Madison, WI.
Johnson & Johnson Medical Devices is currently $20 billion in worldwide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Senior Regulatory Affairs Program Lead, NeuWave will complete the day-to-day Regulatory Affairs operations. In addition, these jobs exhibit a high degree of independent judgment and execute on plans that directly impact the operational results of business units.
Responsibilities include but not limited to:
Lead Regulatory Team member supporting continued access of new/modified/current Interventional Solutions products in key regions
Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for new product clearances and approvals
Reviews various changes made to existing products to assess the impact on safety and effectiveness;
Directs and coordinates activities concerned with the maintenance of submission and approval of products to government regulatory agencies.
Provides guidance to project team members regarding regulatory compliance issues.
Provides guidance to business leadership to help maximize the strategy across functional areas
Partners with EU, Regional, Policy, RALI leaders to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's portfolio of products and help drive strategies to achieve a competitive advantage and benefit for the patients.
Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
Interacts with regulatory agency personnel to expedite approval of pending application and to resolve regulatory matters.
Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
Works with team members and commercial partners to oversee the regulatory aspects of new products launches, and the assessment of the impact product changes have on the status of regulatory licenses.
Build and enhance external partnerships
Independently makes decisions regarding work processes or operational plans and schedules
Ensures organization compliance with all applicable regulations and J&J policies
Provides day-to-day instructions and suggested training activities to direct reports (if any)
A minimum of a B.A. /B.S., preferably in a scientific or business discipline is required. An Advanced degree (M.S., M.E., PhD or MD) is a plus.
Previous experience with medical devices, preferably electro-mechanical devices with software is a plus.
Demonstrated track record of executing global regulatory strategies for both new and existing products, that align with business deliverables is required.
Ability to lead and influence others without direct authority is required.
Experience working with professional and trade associations is a plus.
Position will be based in Madison, WI with up to 20% domestic and international travel.
Primary Location United States-Wisconsin-Madison Organization NeuWave Medical, Inc. (6229) Job Function Regulatory Affairs Requisition ID 4968171117