Regulatory Affairs Specialist

Becton Dickinson; Salamanca; Presencial; EUR 27.000 - 29.000; Jornada completa

Descripción de la vacante

BD in Salamanca is hiring a Regulatory Affairs Specialist to support global regulatory activities for in vitro diagnostic devices across the product lifecycle. You will work with R&D, QA, Manufacturing, and Medical Affairs to ensure regulatory compliance and market access worldwide.

The role requires a Bachelor's in a related scientific field, 1–3 years of regulatory/quality experience, and strong English communication. EU IVDR/FDA knowledge is preferred; the position is based on site in Spain.

Formación

• Bachelor's degree in Biology, Biotechnology, Biomedical Sciences, Pharmacy, Life Sciences, or related field.
• Master's degree in Regulatory Affairs, Cell Biology, Health Sciences, Health Administration, Biotechnology preferred.
• 1–3 years of professional regulatory affairs/quality experience in medical devices or IVDs.
• Strong written and verbal English communication.

Responsabilidades

• Develop, maintain, and support global regulatory strategies for IVD devices throughout the lifecycle.
• Prepare, review, and maintain regulatory submissions, product registrations, technical documentation, and conformity declarations.
• Ensure compliance with FDA, EU IVDR, UK regulations, Health Canada, and other international frameworks.
• Conduct regulatory impact assessments and support change management across product manufacturing, labeling, and post‑market changes.
• Collaborate with cross‑functional teams to embed regulatory requirements in development and lifecycle management.
• Review labeling, IFUs, promotional materials for regulatory compliance and support audits/inspections.

Conocimientos

English proficiency

Educación

Bachelor's degree in a related scientific discipline

Master's degree in Regulatory Affairs or related field

Descripción del empleo

About the role

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. We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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.

• 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

Salary range for this role: 27000€ - 29000€

Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary Range Information €26,300.00 - €40,100.00 EUR Annual BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state‑of‑the‑art technology and cutting‑edge research in the battle to fight and cure infectious diseases.

Primary Work Location

ESP Salamanca
Additional Locations
Work Shift

Benefits and Compensation

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Equal Opportunity Employer

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Additional

Join our company and see how you can become a part of one global mission to make a difference in human health.