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Senior Regulatory Affairs Program Lead

Company: J&J Family of Companies
Location: Irvine
Posted on: August 4, 2022

Job Description:

Johnson & Johnson Vision Care, Inc is recruiting for a Senior Regulatory Affairs Program Lead located in Irvine, CA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. Thats why, through our operating companies, weve developed solutions for every stage of lifeto help people see better, connect better and live better. We partner with eye care professionals to provide some of the worlds leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn. Key Responsibilities: + Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Under little to no supervision, prepare US, EU and Canada regulatory submissions, including, but not limited to 510(k)s, PMA/HDE Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of products.+ Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches+ Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers+ Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.+ Defines data and information needed for regulatory approvals.+ Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials 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.+ Partners with other functions to define and obtain data to assist with regulatory submissions.+ Adheres to environmental policy and procedures and supports department environmental objectivesQualificationsRequired:+ Minimum 6 years of working experience within Medical Device Regulatory environment or equivalent is required+ Bachelors Degree Scientific Discipline is required+ Excellent written, verbal communication and presentation skills is required+ 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 is required+ Takes accountability for the achievement of business goals and objectives is required+ Ability to partner and influence key stakeholders on NPD and Lifecycle teams is required Preferred: + Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices is preferred+ 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.+ 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) is preferred+ Knowledgeable in US, EU and International Regulations Leadership is preferred+ Connect by encouraging and supporting internal collaboration across levels, creating effective solutions is preferred+ Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels is preferred+ Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact is preferred+ Engages with regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives is preferred+ Lead by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions is preferred+ Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearance is preferred+ Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives is preferredThe base pay range for this position is $101,500 - $142,000.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.For additional general information on company benefits, please go to:+ Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds 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.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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit LocationUnited States-California-Irvine-31 Technology DrOther LocationsNorth America-United StatesOrganizationJohnson & Johnson Surgical Vision, Inc (6234)Job FunctionRegulatory AffairsRequisition ID2206033786W

Keywords: J&J Family of Companies, Irvine , Senior Regulatory Affairs Program Lead, Other , Irvine, California

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