Senior Manager, Regulatory Affairs

🕒 Abril 25

🐊 Florida, New Jersey, +1 estados a mais – Remoto

🐊 Florida – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote

💵 $155.677 - $202.380 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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QuidelOrtho

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

⚕️ Seguro de Saúde

💊 Farmacêutico

🔬 Ciência

Healthcare Insurance • Pharmaceuticals • Science

A QuidelOrtho é uma corporação global focada em transformar dados diagnósticos em insights acionáveis para gerar melhores desfechos em saúde. A empresa oferece uma ampla gama de soluções diagnósticas, incluindo kits de autoteste de COVID-19 para uso doméstico, química clínica, produtos de imunoensaio, diagnósticos moleculares e soluções automatizadas para prestadores de serviços de saúde. Seus produtos são projetados para uso em diversos ambientes — do lar ao hospital e do laboratório à clínica — garantindo resultados diagnósticos rápidos e confiáveis. A QuidelOrtho busca impulsionar um futuro mais saudável ao fornecer inteligência acionável em tempo real e expertise líder no setor.

Descrição

• Manage and support a team of managers and employees of different levels. • Responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. • Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. • Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. • Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. • Make judgments about the operational impact of proposed actions, and identify and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. • Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. • Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. • Identify and/or lead process improvement projects to streamline current activities and increase department efficiencies. • Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. • Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. • Perform other work-related duties as assigned.

🎯 Requisitos

• Bachelor’s degree in a scientific or related discipline; or equivalent combination of education and experience. • 10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry. • 7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports). • Review and approval of product labeling and promotional and advertisement brochures and multimedia content. • Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s). • Previous people management experience. • Excellent interpersonal, teamwork, and verbal/written communication skills. • Good organizational skills and an ability to manage multiple tasks/projects/priorities. • The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed. • Ability to mentor and coach junior level staff as well as cross-train with peers.

🏖️ Benefícios

• medical, dental, vision, life, and disability insurance • 401(k) plan • employee assistance program • Employee Stock Purchase Plan • paid time off (including sick time) • paid Holidays