Johnson & Johnson Careers
Sr Regulatory Affairs Program Lead
Requisition ID: 5858180704
Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Sr. Regulatory Affairs Program Lead, located in Shoreview, MN, supporting Torax Medical, Inc.
Torax Medical specializes in developing and marketing medical devices designed to treat sphincter disorders utilizing its technology platform, Magnetic Sphincter Augmentation (MSA).
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity.
The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Torax Medical's core technology applies the unique properties of specialized magnets to precisely restore the barrier function of sphincters. Torax Medical’s technology platform, Magnetic Sphincter Augmentation, uses the attraction forces to augment weak or defective sphincter muscles to treat Gastroesophageal Reflux Disease (GERD)..
The Regulatory Affairs (RA) Program Lead/Sr. RA Program Lead is responsible for the initiation and management of global regulatory submissions to assure achievement of business objectives and government compliance by proactively evaluating existing and emerging regulatory and quality requirements. Working cross-functionally, he/she is accountable to develop regulatory plans and submissions for new products and changes to existing products thereby achieving, in target markets, timely regulatory approval for Torax Medical. Additionally, the Program Lead is responsible for review of customer facing and internal documentation to ensure Regulatory compliance. He/she is responsible for following established Torax Medical and Ethicon Quality System practices and completing all specific training requirements.
- Plans, coordinates, and executes regulatory submissions according to regulatory strategies to meet company objectives
- Serve as a regulatory liaison with FDA and international regulatory bodies on behalf of Torax to facilitate timely and favorable review of submissions and issues
- Coordinates expanding global presence with in country affiliates. Responsible for ensuring timely response to inquiries to global agencies
- Project team member for maintenance and initiation of IDE applications, Technical Files, and Premarket Approval Submissions and supplements. Responsible for informing management of project progress and establishing project timelines in accordance with department and corporate objectives
- Participates on project teams as primary Regulatory Affairs representative providing appropriate information on regulatory issues and obtaining needed information to meet regulatory requirements
- Reviews labeling for compliance with regulations and ensures that claims are substantiated and sustained
- Maintains current knowledge base on existing and emerging regulations, standards, and guidance documents
- Ensures organizational compliance with FDA regulations pertaining to regulatory submissions
- Ensures organizational compliance with international regulations and requirements pertaining to regulatory submissions
- Completes required annual reporting, clinical/risk reporting, and device listing/registrations
- Provides regulatory review for internal change orders and other quality records to ensure regulatory compliance
- Works with Clinical to achieve and maintain Good Clinical Practice compliance as required
- Works with Quality and Research & Development organizations to achieve and maintain FDA Quality System Regulation compliance and compliance with ISO requirements
- Bachelor’s degree is required; scientific or technical field discipline is preferred
- Six (6) years minimum in a regulated environment with four (4) years direct regulatory medical device submission experience preparing 510(k), IDE and PMA submissions, including supplements and annual reporting is required
- Three (3) years minimum experience of working knowledge and application of FDA regulations and requirements with the ability to integrate into projects is required
- Two (2) years minimum international submission preparation experience is required
- Three (3) years minimum developing, interpreting or applying standards, guidelines and special controls is preferred
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Torax Medical, Inc