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Senior Regulatory Affairs Specialist
Requisition ID: 4982180304
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Specialist located in Cincinnati, Ohio.
The Ethicon 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 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. Ethicon, with their deep expertise in minimally invasive surgery and advanced instrumentation is developing surgical instruments for Verb Surgical's new robotics-assisted digital surgery platform.
The Senior Regulatory Affairs Specialist executes the Regulatory Affairs Robotics platform strategy, supports regional and country product registrations, and monitors and assesses impacts of product specific regulations. He/she will provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified global product launches and New Product Development regulatory activities. This individual works closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling Center of Excellence, global Regulatory Affairs affiliates, as well as works collaboratively with external partners at Verb.
- The Senior Regulatory Affairs Specialist will prepare and submit regulatory information required to obtain global market access including preparation, writing and filing of 510(k)s, technical files, design dossiers and international registration dossiers.
- He/she will proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
- The Lead will execute on plans that directly impact operational results using independent judgment and successfully balance project priorities related to the Robotics Platform.
- He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- The role also assists in the development of best practices for Regulatory Affairs processes.
• B.A./B.S. within a technical related discipline with a minimum of 6 years relevant/ regulated industry experience is required.
• Previous experience with medical devices is strongly preferred.
• Previous experience with health authority meetings/interactions is strongly preferred.
• A demonstrated track record of developing and executing regulatory strategies that align with business deliverables is required.
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is highly desirable.
• Working knowledge of how global regulations impact product registration is required.
• Demonstrated ability to influence key stakeholders is required.
• The ability to work collaboratively in a highly matrixed environment is required.
• Ability to build and sustain productive partnerships across multiple platforms is required.
• Evaluate new regulatory requirements as well as regulatory changes and correctly assess business impact is required.
• Plan and execute complex projects through timely completion with positive business results is required.
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.
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