Sr. Regulatory Affairs Program Lead, Medical Device - Wound Closure & Repair
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Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Regulatory Affairs Program Lead, Medical Device - Wound Closure & Repair. This role is based in Somerville, NJ and may require approximately 10% travel.
Johnson & Johnson Medical Devices is currently $20 billion in Worldwide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to project teams in submission and commercial strategy development and executes upon these strategies to support optimal 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 helps to assess data and information needed for regulatory approvals in conjunction with cross-functional product development teams. Additionally, he/she guides conformance with applicable regulations in support of claims and promotional materials for the Wound Closure Heritage products. The role assures that advertising and promotional materials meet applicable regulatory requirements by evaluating data to support marketing claims and assure on-label promotion of Wound Closure Heritage products
Position duties & responsibilities:
• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares responses and leads meetings for regulatory agencies' questions and other correspondence.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Builds timelines for submissions under the direction of senior regulatory affairs staff.
• Provides solutions to extremely complex problems in which data analysis requires an evaluation of intangible variables.
• Provides regulatory guidance to project teams.
• Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
• Defines data and information needed for regulatory approvals
• Develops labeling specifications and approves proposed labeling and packaging, after evaluating conformance to regulations
• Provide Regulatory Affairs support during internal and external audits
• Plans schedules for regulatory deliverables on a project and monitors project through completion
• Assists in the development of best practices for Regulatory Affairs processes
• Represents Regulatory Affairs on cross-functional project teams
• Collaborates with global Regulatory Affairs affiliates in support of local strategies for global product launches
• Partners with other functions to define and obtain data to assist with regulatory submissions
• Review content of advertising and promotional materials to assure compliance with applicable regulations and J&J regulatory requirements.
• May review non-promotional materials (e.g., sales training, professional education, sales and marketing communications, press releases, and advisory panel presentations) to assure compliance with applicable regulations and J&J regulatory requirements.
• May evaluate data and/or published literature which supports proposed marketing claims.
• Partner and builds positive relationships with Franchise RA team and internal partners (e.g., Marketing, Medical, Clinical, Pre-Clinical, Legal) to resolve issues related to promotional materials.
• Communicate regulatory requirements to originators of ad/promo materials.
• Manage a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property.
• May support regulatory submissions where US FDA approval of device advertisements is required.
Functional and Technical Competencies:
• Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (for example, represents Regulatory in the product recall and recall communication process).
• Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives.
• Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).
• Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.
• Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
• Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
• Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
• Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances and approvals
• A minimum of a B.A. /B.S. degree is required preferably within a scientific or technical discipline.
• An advanced degree (i.e. M.S., M.E.) is preferred
• A minimum of 6 years of regulatory affairs or related/equivalent experience is required
• Previous experience independently authoring 510K and CE Mark regulatory submissions is required
• Previous experience reviewing content of advertising and promotional materials to assure compliance with applicable regulations is required
• Previous experience interacting directly with Health Authorities is required.
• Provide Regulatory Affairs support during internal and external audits is preferred
• Previous experience managing or leading multiple projects simultaneously is required.
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, is preferred.
• The ability and willingness to be based in Somerville NJ with minimal travel (10% or less) is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Somerville-
Ethicon Inc. (6045)