Senior Manager, Regulatory Affairs

🕒 il y a 2 mois

🐊 Florida, New Jersey, +1 états de plus – Distant

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

💵 $155 677 - $202 380 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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QuidelOrtho

Site WebLinkedInTous les Emplois

5001 - 10000 employés

⚕️ Assurance santé

💊 Pharmaceutique

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

QuidelOrtho est une entreprise mondiale axée sur la transformation des données de diagnostic en informations exploitables pour de meilleurs résultats de santé. Elle propose une large gamme de solutions de diagnostic, notamment des kits de test COVID-19 à domicile, des produits de chimie clinique, des produits immuno-dosage, des diagnostics moléculaires et des solutions automatisées pour les prestataires de soins de santé. Leurs produits sont conçus pour être utilisés dans divers environnements, de la maison à l'hôpital, du laboratoire à la clinique, afin de garantir des résultats de diagnostic fiables et rapides. QuidelOrtho vise à promouvoir un avenir plus sain en fournissant des informations exploitables en temps réel et une expertise de premier plan dans l'industrie.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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