HireDiversity

Somerville, NJ, US

MANAGER REGULATORY AFFAIRS-7659121019

Description

The Ethicon Surgical Care business of the Medical Device and Diagnostics sector of Johnson & Johnson is recruiting for a Manager, Regulatory Affairs to be located in Somerville, NJ.

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 electiveness 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.

The Regulatory Affairs Manager administers the day-to-day Regulatory Affairs operations by directly or indirectly managing teams of employees or managing third-party vendors. In addition, these jobs exhibit a high degree of independent judgment and execute on plans that directly impact the operational results of business units. The Regulatory Manager will work and provide leadership / advice to internal cross-functional team members in order to create supporting documentation demonstrating compliance to global regulatory requirements. He/She will provide tactical and strategic regulatory leadership to the organization for a specific product(s) or project(s). He/She will work/consult with internal/external regulators to assure the policies/practices adopted by Ethicon will be as effective and as efficient as possible.

The Regulatory Affairs Manager serves as Project Manager for assigned products lines to ensure all regulatory documents are complete, accurate and well-maintained. Works with team members and commercial partners to oversee the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses. Interprets regulatory requirements and determines strategies to obtain license registrations or approvals. Ensures organization compliance with all applicable regulations and J&J policies. Assures all records and device inspections are consistent with global regulatory requirements and the company's quality management system. Coordinates and/or submits licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. Responds to product information requests. Researches and collects information and data to support periodic reports to regulatory agencies. Provides Regulatory Affairs support during internal and external audits. Manages workflow, processes and internal tools, and makes recommendations for improvements. Provides leadership in the development of best practices for Regulatory Affairs processes. Gives direction/consultation to junior-level RA Associates.

Qualifications


A minimum of a Bachelor's degree, preferably in an Engineering or Scientific field, with a minimum of 8 years of Regulatory Affairs experience is required. A minimum of 4 years of Regulatory Affairs experience with a PhD, PharmD or Master's degree is preferred. Regulatory Affairs experience encompassing interactions with US and Ex-US regulatory authorities is required. Medical Device experience is required. Combination products experience is preferred. Proven leadership and people management experience is preferred.

Up to approximately 10% international and domestic travel may be required. This position will be located in Somerville, NJ.

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Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)