Associate Director Regulatory Affairs M / F

buscojobs España; Burgos; Híbrido; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Una empresa consolidada en el sector de dispositivos médicos busca un Director Asociado de Asuntos Regulatorios para liderar las presentaciones regulatorias y el cumplimiento. Este papel involucra dirigir equipos de proyecto y asegurar la conformidad con las regulaciones. Se requiere experiencia sólida en Ciencias de la Vida, preferiblemente en el campo dental, y habilidades de liderazgo y comunicación excepcionales. Se ofrece un paquete de compensación competitivo y la opción de trabajo remoto parcial.

Servicios

Seguro de salud privado

Programa de Asistencia al Empleado

Programa de Aprendizaje y Desarrollo

Opción de trabajo remoto parcial

Formación

• Mínimo 5 años de experiencia en Asuntos Regulatorios en una empresa de Dispositivos Médicos.
• Experiencia deseable en regulación de productos farmacéuticos, biológicos y productos combinados.

Responsabilidades

• Gestiona las presentaciones regulatorias, asegurando cumplimiento y aprobaciones a tiempo.
• Proporciona dirección regulatoria a los equipos de proyecto y estrategias para nuevos productos.
• Supervisa el etiquetado y materiales promocionales para cumplimiento regulatorio.

Conocimientos

Comunicación

Negociación

Orientación al detalle

Gestión de equipos

Educación

Licenciatura en Ciencias de la Vida

Certificado de Asuntos Regulatorios

Título Avanzado (Preferido)

Descripción del empleo

Associate Director Regulatory Affairs M / F

Gerona

EUR 40.000 - 80.000

An established industry player is seeking a Regulatory Affairs Manager to oversee regulatory submissions and compliance for innovative medical devices. This role involves directing project teams, ensuring adherence to regulations, and fostering a collaborative environment. The ideal candidate will have a strong background in life sciences and regulatory affairs, with a focus on the dental field. Join a diverse and inclusive team that values personal authenticity and accountability, and contribute to shaping the future of patient care through innovative solutions. This position offers exciting career prospects and the opportunity to work in a dynamic global environment.

Competitive Compensation Package

Permanent Contract

Partially Remote Work Option

Private Health and Dental Insurance

Employee Assistance Program

Learning & Development Program

• 5+ years of experience in Regulatory Affairs in a Medical Device company.
• Strong communication and negotiation skills with regulatory agencies.
• Manage regulatory submissions and ensure compliance for product approvals.
• Provide regulatory direction and strategies for new product development.

Regulatory Affairs

Communication Skills

Team Management

Detail Orientation

Degree in Life Sciences

Advanced Degree (Preferred)

Regulatory Affairs Certificate

We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you’ll consider being a part of it!

About the role:

This position manages all facets of regulatory support to market ZimVie products such as the development of regulatory submissions, provision of guidance and consultation for international regulations, interaction with governmental agencies, and managing a staff of regulatory professionals. The position holder will contribute to the development of the Regulatory Affairs strategy.

What you’ll be doing:

• Directs regulatory submissions, including dossier development and electronic publication, ensuring compliance and timely approvals.
• Provides regulatory direction to project teams, defining strategies for new products and communicating them to the RA group.
• Oversees labeling, package inserts, promotional materials, and product changes for regulatory compliance.
• Interprets and applies regulations to business practices, offering strategic guidance to the organization.
• Establishes and ensures compliance with ZimVie RA policies and procedures, including training initiatives.
• Maintains communication on regulatory requirements, emerging issues, and interactions with regulatory agencies.
• Manages departmental priorities, overseeing tasks, projects, and the development of regulatory professionals.

What you’ll need:

• Degree in life sciences, technical (engineering), or related field. Advanced degree preferred.
• Regulatory Affairs Certificate and minimum of 5 years prior RA experience in Medical Device company, ideally in the Dental field.
• Experience in the areas of drug, biologics, and combination products regulations is also desirable.
• Team management experience, fostering collaboration and professional growth.
• Detail-orientation and high quality focus.
• Ability to assess business risks and develop regulatory strategies.
• Strong communication and negotiation skills, effectively engaging with Regulatory agencies, management, and cross-functional teams.
• Customer- and results-oriented mindset.

Travel Requirements: Up to 25%

What we offer:

Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset. Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.

ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:

• Competitive compensation package
• Permanent contract
• Partially remote work option available
• Private life, health and dental insurance
• Employee Assistance Program

Do you want to know more about us? Click HERE to watch our story.

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity.

• Requisition ID: 3067

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