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Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior RA Program Lead, Biosurgery to be located in Raritan, NJ and support the Ethicon Biosurgery portfolio of products. Ethicon 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 minimally invasive and open surgical procedures. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. Biosurgery is based in Raritan, New Jersey and develops market leading medical device, biologic and combinations product hemostasis solutions targeting conventional open and minimally invasive surgeries. The Senior RA Program Lead, Biosurgery will administer the day-to-day Regulatory Affairs operations independently. 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 Class II, Class III medical devices, combination products and biologics, with minimal guidance. Ensure alignment of regulatory strategy to business strategy across all functional areas. • Assess regulatory pathways, develops global strategy and complies and executes regulatory submissions (IDE/PMA/510(k)/PMA/BLA/Design Dossier) required to obtain registration for new products under development and throughout the product’s life cycle. Prepares and facilitates responses to healthy authority inquiries. • Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for product clearances and approvals • Manages MDR updates in coordination with MDR execution and implement changes globally • Reviews various changes made to existing products to assess the impact on safety and effectiveness and determine appropriate RA pathway for implementation • Review advertisement and promotional product material to ensure compliance to regulations • Partners with EU and Regional 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. • Works with team members and commercial partners to oversee the regulatory aspects of new products launches • Independently makes decisions regarding work processes or operational plans and schedules • Possesses excellent written and verbal communication skills • Experience in preparation of US Regulatory files as well as European Technical Files and/or Design Dossiers is preferred Qualifications Bachelor degree from accredited college or university and 2 years of regulatory affairs or related/equivalent experience OR an advanced degree (M.S., M.E., Ph.D., J.D., or M.D.) with related experience or equivalent experience OR over 5 years of relevant regulatory affairs experience. Experience with authoring and managing Class III medical device submissions is required Experience with combination products or biologics is preferred. Previous experience working with cross-functional product development teams is required Previous experience reviewing various changes made to existing products to assess the impact on safety and effectiveness is required. Ability to work independently, as well as collaborate with a large team to achieve project success Experience in healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry is required. This position is located in Raritan, New Jersey and may require up to 10% travel. Other locations will be considered for the right candidate. 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. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Primary Location United States-New Jersey-Raritan-1000 US HIghway 202 Organization Ethicon Inc. (6045) Job Function Regulatory Affairs Requisition ID 2206015987W
Child care benefits
Short term disability