Regulatory Affairs Specialist

BD; Salamanca; Presencial; EUR 26.000 - 40.000; Jornada completa

Descripción de la vacante

BD is seeking a Regulatory Affairs Specialist to manage global regulatory activities for in vitro diagnostic (IVD) medical devices across the product lifecycle. You will help craft strategies, prepare registrations and ensure compliance worldwide, working with R&D, QA, Manufacturing, and Medical Affairs.

The role requires a science background, strong regulatory knowledge, and the ability to communicate complex requirements to diverse teams.

Formación

• Bachelor's degree in Biology, Biotechnology, Biomedical Sciences or related field.
• 1–3 years experience in Regulatory Affairs, Quality or Life Sciences.
• Strong written and verbal English communication.
• Ability to interpret technical and regulatory information.
• Able to work effectively in cross-functional global teams.

Responsabilidades

• Develop, maintain and support global regulatory strategies for IVD devices.
• Prepare and maintain regulatory submissions, registrations and technical docs.
• Support compliance with FDA, EU IVDR, UK and Health Canada requirements.
• Conduct regulatory impact assessments for changes in product, manufacturing or labeling.
• Monitor regulatory developments and communicate impacts to stakeholders.
• Collaborate with R&D, QA, Manufacturing, Medical Affairs and Marketing on lifecycle activities.
• Review labeling, IFUs and promotional materials for regulatory compliance.
• Support interactions with authorities and Notified Bodies, including submissions.
• Assist audits, document regulatory procedures and provide training.
• Contribute to post-market obligations and lifecycle maintenance.

Conocimientos

Regulatory affairs

English communication

Cross-functional teamwork

Educación

Biology/Biotech degree

Regulatory affairs advanced degree (plus)

Descripción del empleo

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.

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?

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.

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.

Primary Work Location

ESP Salamanca

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. The 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. Our pay is based on the role and the necessary skills and education to perform it successfully. The 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 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 Range Information

€26,300.00 - €40,100.00 EUR Annual