Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Regulatory Affairs Consultant: Medical Device and Combination Product Expert
Primary Location: Italy, Milan Additional Locations: United Kingdom, Remote ID de la oferta R0000039531 Categoría Regulatory Affairs Fecha de publicación 03/09/2026Overview
Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.
Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Estratégico
- Constructor de relaciones
- Solucionador de problemas
- Orientado al detalle
- Impulsado por los resultados
Acerca de este rol
About the Role
We are seeking an experienced Regulatory Affairs professional to lead medical devices and combination products regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for clinical investigations and marketing authorizations, and serve as the key regulatory representative for our global project teams.
The role can be home or office based in various European locations.
Key Responsibilities
Develop comprehensive regulatory strategies and technical documentation of medical devices and combination products.
Represent the regulatory affairs function in global project teams and governance meetings.
Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings.
Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization.
Maintain global regulatory databases with accurate and current information.
Collaborate with CMC and QA departments on device change control processes and global submission requirements.
Support internal and external audits related to medical device quality systems.
Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.
Skills and Experience:
University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.
Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products.
In-depth knowledge of global medical device regulations, in particular EU MDR. Knowledge of US FDA regulation would be a plus.
Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., clinical investigations, Notified Body opinions, CE certifications).
Familiarity with medical devices regulatory framework including EU-MDR, ISO 13485 and ISO 14155.
Experience also in vitro diagnostic devices would be a plus.
Strong track record representing companies during regulatory audits and inspections.
Excellent communication and interpersonal skills.
Fluent in English, written and spoken.
Proficiency with regulatory systems including Veeva and TrackWise would be a plus.
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
