Senior Regulatory Affairs Leader

2 weeks ago


Portage, Michigan, United States Stryker Full time

Flexibilidad Laboral: Híbrido

Actualmente estamos buscando un Senior Regulatory Affairs Leader para nuestra división de Instrumentos.

¿Quiénes somos?

  • Pensadores estratégicos. Personas que disfrutan analizar datos o tendencias con el propósito de planificación, pronóstico, asesoramiento, presupuestación, informes u oportunidades de ventas.
  • Orquestadores orientados a objetivos. Personas que pueden coordinar y enfocar efectivamente el trabajo de empleados calificados hacia un objetivo importante, priorizando las actividades correctas que conducen al éxito.
  • Evaluadores orientados a los negocios. Personas que interpretan efectivamente la información para demostrar los efectos de iniciativas comerciales, regulaciones y tendencias de la industria para equipos de ventas, gestión y liderazgo.
¿Qué harás?

Como Senior Regulatory Affairs Leader, apoyarás el desarrollo de nuevos productos para lanzamientos tanto nacionales como internacionales, contribuyendo al desarrollo y actualización de estrategias regulatorias basadas en cambios normativos. Serás considerado el recurso del equipo regulatorio global, asegurando el cumplimiento regulatorio mediante evaluaciones y presentaciones exhaustivas relacionadas con autorizaciones de productos ante autoridades competentes.
  • Evalúa las conexiones entre tendencias globales, sociales y económicas; preocupaciones de los interesados y requisitos regulatorios; y las implicaciones para la estrategia regulatoria.
  • Participa en actividades de defensa de carácter más avanzado y estratégico.
  • Desarrolla y actualiza estrategias regulatorias globales, regionales y multicountry, alineando las estrategias regulatorias con las estrategias organizacionales.
  • Proporciona orientación para integrar consideraciones regulatorias en la estrategia de entrada y salida de productos a nivel global.
  • Identifica rutas regulatorias para diseños de productos iniciales y proporciona insumos a las partes interesadas internas.
  • Analiza la adecuación de las rutas regulatorias propuestas y la estrategia para los diseños de productos iniciales, recomendando cambios o refinamientos basados en resultados regulatorios iniciales.
  • Evalúa todos los requisitos y posibles obstáculos para el acceso al mercado y distribución, desarrollando soluciones para abordar obstáculos anticipados.
  • Evalúa el impacto de las regulaciones cambiantes en estrategias pre y post aprobación.
  • Proporciona comprensión profunda y capacidad para incorporar estrategias regulatorias que aceleren el desarrollo de productos destinados a condiciones médicas graves o que aborden necesidades médicas no satisfechas.
  • Negocia con autoridades regulatorias sobre cuestiones complejas a lo largo del ciclo de vida del producto.
  • Establece relaciones de trabajo e interfaces con múltiples organizaciones gubernamentales y no gubernamentales que impactan el acceso al mercado y la distribución.
  • Identifica la necesidad de desarrollar y ejecutar nuevos procedimientos regulatorios y procedimientos operativos estándar.
  • Desarrolla y gestiona programas que capaciten a las partes interesadas sobre requisitos regulatorios actuales y nuevos para asegurar el cumplimiento en toda la organización.
  • Proporciona insumos estratégicos y orientación técnica sobre requisitos regulatorios globales a los equipos de desarrollo de productos.
  • Evalúa riesgos de problemas de seguridad de productos y clínicos durante las fases clínicas y recomienda soluciones regulatorias.
  • Evalúa cambios propuestos en preclínicos, clínicos y fabricación para soluciones de presentación regulatoria.
  • Revisa y evalúa propuestas a autoridades regulatorias sobre rutas regulatorias y planes clínicos.
  • Monitorea la implementación de estrategias regulatorias en relación con problemas de seguridad de productos y clínicos.
  • Proporciona conocimiento y análisis crítico de inspecciones preaprobatorias y relaciones con investigadores clínicos.
  • Proporciona orientación regulatoria sobre estrategias para reclamaciones/etiquetado de productos propuestos.
  • Asegura que los datos clínicos y no clínicos sean consistentes con los requisitos regulatorios y respalden las reclamaciones del producto propuesto.
  • Gestiona el desarrollo de registros electrónicos (eCTD) y en papel.
  • Asegura que existan políticas y procedimientos para la revisión y aprobación interna de presentaciones regulatorias.
  • Lidera negociaciones clave e interacciones con autoridades regulatorias durante todas las etapas del desarrollo y proceso de revisión.
  • Prepara equipos multifuncionales para interacciones con autoridades regulatorias, incluidos paneles/comités asesores.
  • Posee y aplica conocimientos estratégicos y avanzados, habilidades y comprensión de los marcos regulatorios y legales, requisitos regulatorios, legislación, procesos y procedimientos.
¿Qué necesitas?
  • Título universitario requerido, preferiblemente en Ingeniería, Ciencia o relacionado.
  • MS en Ciencias Regulatorias o título avanzado preferido.
  • Más de 9 años de experiencia en una industria regulada por la FDA requerida; preferiblemente con dispositivos médicos.
  • Más de 7 años de experiencia en Asuntos Regulatorios de Dispositivos Médicos requerida.
  • Experiencia previa redactando presentaciones regulatorias a la FDA requerida.
  • Experiencia interactuando con agencias regulatorias requerida.
  • RAC(s) deseado.
  • Comprensión profunda de las Regulaciones del Sistema de Calidad (21 CFR), Directivas de Dispositivos Médicos (MDD) y orientación MEDDEV.
  • Comprensión profunda de otras regulaciones relacionadas con la Autorización de Mercado Previo y Soporte Post Mercado.
  • Experiencia previa con dispositivos médicos de Clase II/III requerida, experiencia con software o PPE deseada.
  • Habilidades avanzadas en PC con dominio del Paquete de Microsoft Office, incluyendo Excel.
Porcentaje de Viaje: 20%

Stryker Corporation es un empleador que ofrece igualdad de oportunidades. Los solicitantes calificados recibirán consideración para el empleo sin distinción de raza, etnia, color, religión, sexo, identidad de género, orientación sexual, nacionalidad, discapacidad o estatus de veterano protegido.

  • Portage, Michigan, United States Stryker Full time

    Join a Leading OrganizationWe are proud to be recognized as one of the World's Best Workplaces by Fortune Magazine, offering 12 paid holidays annually.About the RoleWe are currently looking for a Senior Regulatory Affairs Leader to join our Instruments division, with the flexibility to work remotely across the United States.Who We SeekWe value strategic...


  • Portage, Michigan, United States Stryker Full time

    Position Overview:As a Senior Regulatory Affairs Consultant, you will play a crucial role in facilitating the development of innovative products for both local and global markets. Your expertise will be essential in shaping and refining regulatory strategies in response to evolving regulatory landscapes.Key Responsibilities:- Collaborate with...


  • Portage, Michigan, United States Ledgent Technology Full time

    Job Summary:Ledgent Technology is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for coordinating and preparing document packages for regulatory submissions from various areas of the company.Key Responsibilities:Collect and compile all necessary materials for regulatory...


  • Portage, Michigan, United States iMPact Business Group Full time

    Job Summary:We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our team at iMPact Business Group. As a key member of our Business Services team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the preparation of document packages for regulatory submissions.Key...


  • Portage, Michigan, United States The Judge Group Full time

    Job Summary:The Judge Group is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the medical device industry.Key Responsibilities:Collect and submit data from customers for auditable recordsCoordinate and...


  • Portage, Michigan, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our product field action team, you will play a critical role in supporting the collection and submission of data from customers for auditable records.Key...


  • Portage, Michigan, United States StoryPoint Full time

    Senior Care Team Leader / Medication TechnicianStoryPoint PortageShift Premium for Evening and Night ShiftsAccess to Earned Wages Before PaydayOpportunities for Community DevelopmentSupportive Team Atmosphere and much moreThe Senior Care Team Leader is tasked with delivering compassionate and individualized support for residents within our...


  • Portage, Michigan, United States Bickford Senior Living Full time

    About the RoleWe are seeking a skilled and detail-oriented Dishwasher to join our culinary team at Bickford Senior Living. As a Dishwasher, you will play a vital role in supporting our kitchen staff in preparing high-quality meals for our residents.ResponsibilitiesWash and Sanitize Dishes: Ensure all dishes, pots, and pans are thoroughly cleaned and...


  • Portage, Michigan, United States Stryker Group LLC Full time

    Position OverviewThe Customer Care Team Leader is tasked with overseeing the Customer Support division at Stryker Group LLC. This role involves managing the performance of our customer service representatives, ensuring exceptional customer experiences, and driving team engagement and productivity. Daily responsibilities will encompass budget adherence, team...


  • Portage, Michigan, United States RNA Facilities Management Full time

    Job OverviewAbout Us:RNA Facilities Management has been a leader in delivering top-notch cleaning services, facility upkeep, and maintenance solutions since 1991. As a proud member of the U.S. Green Building Association, we adopt a comprehensive strategy to cleaning and facility management. Our 'RNA Quality Standard' is a testament to our commitment to...


  • Portage, Michigan, United States Mint Cannabis Full time

    Job SummaryWe are seeking a highly motivated and experienced Store Manager to join our team at Mint Cannabis. As a Store Manager, you will be responsible for leading a team of 25-50 employees and ensuring the smooth operation of our retail store.Key ResponsibilitiesLeadership and DirectionProvide guidance and support to your team to achieve sales goals and...


  • Portage, Michigan, United States Stryker Full time

    About UsAt Stryker, we are honored to be recognized as one of the World's Best Workplaces by Fortune Magazine. We offer a comprehensive benefits package, including 12 paid holidays each year.Position OverviewWe are seeking a dynamic leader to join our team as the Vice President of Global Medical Manufacturing. This role is pivotal in shaping and executing...

  • Area Director

    5 days ago


    Portage, Michigan, United States Royal Oak Full time

    Job Summary:The Area Director is a key leadership position responsible for overseeing the management of multiple regional manufacturing plants. This role requires a strong understanding of manufacturing operations, quality control, and cost management.Key Responsibilities:Strategic Planning: Assist senior staff members in developing long-term plans, budgets,...


  • Portage, Michigan, United States Stryker Full time

    Work Flexibility: Remote Key Responsibilities: • Collaborates with the Employee Relations leadership to establish, articulate, and implement the strategy for employee relations and HR investigations. • Offers expert guidance, support, and training to HR partners (HRBPs, Divisional and Group HR leaders) and other stakeholders on various topics, including...


  • Portage, Michigan, United States Royal Oak Full time

    Job SummaryThe Regional Operations Director will be responsible for overseeing the management of multiple manufacturing sites, ensuring the production of high-quality products while meeting cost objectives and quality standards.Key ResponsibilitiesStrategic Planning: Assist senior staff members in developing long- and short-range planning, budgets, policies,...


  • Portage, Michigan, United States Stryker Full time

    Work Flexibility: Onsite Who we seek: Skilled communicators. Individuals who can clearly interpret information and effectively convey results and recommendations to stakeholders, senior management, and their teams.Connection creators. Leaders who foster relationships across teams and departments, facilitating cross-functional...


  • Portage, Michigan, United States Stryker Full time

    Work Flexibility: Remote Key Responsibilities: • Collaborates with the Employee Relations leadership to formulate, define, and implement the employee relations and HR investigation strategy and operational model. • Offers employee relations guidance, support, and training to essential partners in HR (HRBPs, Divisional and Group HR leaders), along with...


  • Portage, Michigan, United States Stryker Full time

    Work Flexibility: Remote Key Responsibilities: • Collaborates with the Employee Relations leadership to formulate, define, and implement the employee relations and HR investigation framework. • Offers employee relations guidance, support, and training to critical HR partners (HRBPs, Divisional and Group HR leaders), as well as other cross-functional...


  • Portage, Michigan, United States FRESH PERSPECTIVE HOME CARE LLC Full time

    Job OpportunityJob Title: Compassionate Caregiver - Home Health AideJob Summary:Fresh Perspective Home Care LLC is seeking a compassionate and dedicated Caregiver and Home Health Aide to join our team in providing personalized senior care. As a valued member of our team, you will provide hands-on care and companionship to our clients, assisting them with...


  • Portage, Michigan, United States StoryPoint Full time

    Job OverviewDining Room ManagerStoryPoint of PortageThe Dining Room Manager is responsible for overseeing the efficient operation of the front-of-house services, ensuring high standards of production, productivity, quality, and customer satisfaction. This role involves supervising and coordinating the activities of dining room staff to deliver prompt and...