Regulatory Affairs Specialist

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. Somos quienes damos propósito a las posibilidades. BD es una de las empresas globales de tecnología médica más grandes del mundo. Impulsar el mundo de la salud™ es nuestro propósito, y no es para menos. Se requiere la imaginación y la pasión de todos nosotros— desde el diseño y la ingeniería hasta la fabricación y comercialización de nuestros miles de millones de productos MedTech por año— para mirar lo imposible y encontrar soluciones transformadoras que conviertan los sueños en posibilidades. Job Description The Regulatory Affairs Specialist supports global regulatory activities for in vitro diagnostic (IVD) medical devices throughout the product lifecycle. This role is responsible for contributing to regulatory strategy development, regulatory submissions, product registrations, technical documentation, regulatory intelligence, change management assessments, and compliance activities to ensure continued market access worldwide. The position partners closely with cross-functional teams including Research & Development, Quality Assurance, Manufacturing, Clinical Affairs, Medical Affairs, Operations, and Marketing to ensure regulatory requirements are incorporated into product development, maintenance, and commercialization activities. The ideal candidate possesses a scientific background, strong analytical skills, and the ability to independently assess regulatory requirements, evaluate regulatory risks, and translate evolving regulatory requirements into actionable business recommendations. Key Responsibilities - Develop, maintain, and support global regulatory strategies for in vitro diagnostic (IVD) devices throughout the product lifecycle. - Prepare, review, compile, and maintain regulatory submissions, product registrations, technical documentation, declarations of conformity, and supporting regulatory records to support global market access. - Support compliance with applicable global regulatory requirements, including FDA regulations, EU IVDR (EU) 2017/746, UK regulations, Health Canada requirements, and other international regulatory frameworks. - Conduct regulatory impact assessments and support change management activities related to product, manufacturing, supplier, software, labeling, design, process, clinical, and post-market changes. - Monitor evolving regulations, standards, guidance documents, and regulatory intelligence, and communicate regulatory impacts and recommendations to internal stakeholders. - Partner with cross-functional teams including R&D, Clinical Affairs, Quality Assurance, Manufacturing, Medical Affairs, and Marketing to ensure regulatory requirements are incorporated throughout product development and lifecycle management activities. - Review product labeling, Instructions for Use (IFUs), promotional materials, and other product-related documentation for regulatory compliance. - Support interactions with regulatory authorities, Notified Bodies, Competent Authorities, and other regulatory agencies, including preparation of submissions and responses to regulatory inquiries. - Support product lifecycle management activities, including change control assessments, market expansions, performance studies, evidence generation, vigilance reporting, field actions, and regulatory maintenance activities. - Support internal and external audits and inspections, maintain regulatory procedures and quality system documentation, and provide regulatory training and guidance to stakeholders. Required Qualifications - Bachelor's degree in Biology, Biotechnology, Biomedical Sciences, Pharmacy, Life Sciences, or a related scientific discipline. Master's degree in Regulatory Affairs, Cell Biology, Health Sciences, Health Administration, Biotechnology will be a plus. - 1-3 years of professional experience in Regulatory Affairs, Quality, Medical Devices, IVDs, Life Sciences, or a related field. - Strong written and verbal communication skills in English. - Ability to interpret and apply technical and regulatory information. - Ability to work effectively in a cross-functional and global environment. Salary range for this role: 27000€ - 29000€ Why Join Us? Para encontrar propósito en las posibilidades, necesitamos personas que puedan ver el panorama completo y comprender la historia humana que sustenta todo lo que hacemos. Damos la bienvenida a aquellas personas con imaginación y motivación para reinventar el futuro de la atención médica. En BD, descubrirá una cultura en la que puede aprender, crecer y prosperar. Creemos que cuando las personas se reúnen en persona, aprendemos más rápido, colaboramos de manera más profunda y construimos una cultura más sólida. Únase a nosotros y disfrute de un entorno donde la colaboración presencial impulsa su aprendizaje, su progreso y su éxito. Para obtener más información sobre BD, visite https://bd.com/careers . Becton, Dickinson and Company es un empleador que ofrece igualdad de oportunidades. En Becton Dickinson proporcionamos igualdad de oportunidades a todos los candidatos sin distinción de raza, color, religión, edad, sexo, credo, origen nacional, ascendencia, estatus de ciudadanía, estado civil o de unión, situación familiar, orientación afectiva o sexual, identidad o expresión de género, información genética, discapacidad, elegibilidad militar o condición de veterano, y otras características legalmente protegidas. Required Skills Optional Skills . Primary Work Location ESP Salamanca Additional Locations Work Shift En BD, estamos firmemente comprometidos a invertir en nuestros asociados —su bienestar y desarrollo, y a brindar recompensas y oportunidades de reconocimiento que promuevan una cultura basada en el desempeño. Demostramos este compromiso ofreciendo un paquete valioso y competitivo de programas de compensación y beneficios sobre los cuales puede obtener más información en nuestro sitio de carreras en Nuestro compromiso con usted . Se han implementado rangos de salario o tarifas por hora para recompensar a los asociados de manera justa y competitiva, así como para respaldar el reconocimiento del progreso de los asociados, que van desde el nivel inicial hasta los expertos en su campo y la movilidad del talento. Hay muchos factores, como la ubicación, que contribuyen al rango mostrado. El salario o la tarifa por hora que se ofrece a un candidato seleccionado está determinado por su experiencia, educación y habilidades, así como por las leyes laborales y los requisitos del Convenio de Negociación Colectiva (CBA) aplicables al lugar de trabajo. Información sobre el rango salarial €26,300.00 - €40,100.00 EUR Anual