Job Information
J&J Family of Companies Senior Regulatory Affairs Program Lead (Biosurgery) - Ethicon, Inc. in Topeka, Kansas
Senior Regulatory Affairs Program Lead (Biosurgery) - Ethicon, Inc. - 2306152837W
Description
ETHICON, Inc, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Regulatory Affairs Program Lead within the Biosurgery Portfolio! The preferred location for this position is within a commutable distance of Raritan, NJ however remote options within the United States will be considered on a case by case basis.
Ethicon, Inc. develops and markets advanced medical devices for minimally invasive and open surgical procedures. The Ethicon business offers a broad range of products, platforms, and technologies—including hemostats, sutures, surgical staplers, advanced energy, robotic surgery, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of procedures.
The Senior RA Program Lead, Biosurgery has end-to-end responsibility for the life cycle maintenance and new product development launches. The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to product development teams in planning, pre-marketing, and related submissions to support timelines for new/modified product launches. Under little to no supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The Senior RA Program Lead guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Senior RA Program Lead helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
Responsibilities and technical skills include, but are not limited to, the following:
Lead the overall strategy development, implementation, and coordination of regulatory affairs activities for medium to high-risk medical devices with minimal guidance. Ensure alignment of regulatory strategy to business strategy across all functional areas.
Lead the compilation of requirements for global regulatory submissions of our products.
Partner with R&D, QA, Operations, Business Units, and other partners to develop regulatory strategies for health authority submissions or other product related activities.
Apply strategic regulatory thinking along with technical expertise to implement regulatory strategies for product clearances and approvals.
Review product design, labeling, and manufacturing changes to existing products to assess the impact on safety and efficacy.
Review advertisement and promotional product material to ensure compliance to regulations.
The base pay range for this position is $105,000 to $150,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Qualifications
Qualifications
Minimum of a Bachelor's degree is required , Advanced Degree strongly desired ; preferred fields of study include a Science/Biology/Medical related discipline.
Minimum 5 years of Regulatory Affairs or related/equivalent experience (1 with Advanced Degree)
Previous medical device submission experience with medium and high-risk devices is preferred, including experience managing Class III medical device submissions.
Previous experience working with cross-functional product development teams is required.
Previous experience reviewing changes made to existing products to assess the impact on safety and effectiveness is required.
Proven ability to take ownership of work, as well as collaborate with a large team to achieve project success.
Proven track record of leadership success is strongly preferred.
Experience working and aligning with regulatory bodies is desirable.
Possess strong written and verbal communication and presentation skills (technical and/or business).
Experience in the preparation of US Regulatory files as well as European Technical Files and/or Design Dossiers is preferred.
This position is located in Raritan, New Jersey or remote. It may require up to 10% travel.
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.
Primary Location NA-US-New Jersey-Raritan
Other Locations NA-United States
Organization Ethicon Inc. (6045)
Travel Yes, 10 % of the Time
Job Function Regulatory Affairs
Req ID: 2306152837W