Senior Regulatory Affairs Specialist (Temporary - 1 year)

BD; Almaraz; Presencial; EUR 38.000 - 60.000; Jornada completa

Descripción de la vacante

BD, based at the Sendal Almaraz facility in Spain, seeks a Senior Regulatory Affairs Specialist to provide regulatory expertise across its infusion preparation and delivery portfolio. You will support global regulatory activities, ensure product compliance, and drive market access for Class I and II/IIa devices.

You will collaborate with Quality, R&D, Medical Affairs, Marketing, and other teams to maintain technical documentation, submissions, and registrations supporting global launches and

Formación

• Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline
• Approximately 3-5 years of experience in Regulatory Affairs within the medical device industry.
• Strong knowledge of medical device regulatory requirements and processes, with experience supporting regulatory submissions, product registrations, technical documentation, or compliance activities.
• Understanding of Regulation (EU) 2017/745 (EU MDR), UK MDR, U.S. FDA requirements, and/or other international regulatory frameworks.
• Experience working within a regulated environment and ISO 13485 Quality Management System
• Experience contributing to technical documentation, change control activities, product development projects, or sustaining engineering initiatives.
• Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and apply them to practical business situations.
• Ability to manage multiple priorities effectively while maintaining a high level of accuracy and attention to detail.
• Strong written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams to build effective working relationships.
• Develop, maintain, and continuously improve regulatory procedures and processes to ensure ongoing compliance with applicable regulatory and quality management system requirements.
• Proactively identify regulatory risks, issues, and project roadblocks; analyze data to determine root causes and effectively communicate recommendations and mitigation strategies to project teams and management.
• Provide regulatory support for customer inquiries, product information requests, tender submissions, and other commercial activities as required.
• Support continuous improvement initiatives within Regulatory Affairs, Quality Management Systems, and broader business processes to enhance compliance, efficiency, and organizational effectiveness.

Responsabilidades

• Support product development and change control projects by identifying and interpreting applicable regulatory requirements, providing regulatory guidance throughout the project lifecycle, and reviewing and approving project documentation (e.g., design verification reports, technical documentation, labeling) to support regulatory submissions and compliance activities.
• Contribute to first-to-market commercialization opportunities by delivering timely regulatory support and strategies that facilitate efficient product launches and market access.
• Collaborate cross-functionally with Quality, Research & Development, Medical Affairs, Marketing, and other key stakeholders to ensure regulatory requirements are effectively integrated into project deliverables and technical documentation.
• Prepare, maintain, and update technical documentation, regulatory submissions, and product registrations to support market access and continued compliance in global markets.
• Interpret, assess, and communicate applicable regulatory requirements, standards, and guidance documents (e.g., EU MDR, FDA, ISO standards, and international regulations) to cross-functional teams in a clear and actionable manner.

Conocimientos

Global Regulatory

Medical Device Regulations

Product Registrations

Regulatory Support

Educación

Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline

Descripción del empleo

We are the people who give possibilities purpose

Job Description

As a Senior Regulatory Affairs Specialist, you will provide regulatory expertise across BD's infusion preparation and delivery (IPD) portfolio, including disposable infusion sets and accessories used for the administration of fluids and medications. The Sr. Regulatory Affairs position will report to the Sr. Manager, Regulatory Affairs and will be based at the Sendal Almaraz facility in Spain.

The successful candidate will support a global regulatory affairs team through a variety of registration activities that may span new product development, design changes, sustaining engineering, and market access initiatives for Class I and II/IIa devices.

Working closely with Quality, Research & Development, Medical Affairs, Marketing, and other key stakeholders, the candidate will ensure that regulatory requirements are effectively integrated into project planning, execution, and technical documentation, enabling product compliance, global market access, and successful commercialization.

Main responsabilities will include:

• Support product development and change control projects by identifying and interpreting applicable regulatory requirements, providing regulatory guidance throughout the project lifecycle, and reviewing and approving project documentation (e.g., design verification reports, technical documentation, labeling) to support regulatory submissions and compliance activities.

• Contribute to first-to-market commercialization opportunities by delivering timely regulatory support and strategies that facilitate efficient product launches and market access.

• Collaborate cross-functionally with Quality, Research & Development, Medical Affairs, Marketing, and other key stakeholders to ensure regulatory requirements are effectively integrated into project deliverables and technical documentation.

• Prepare, maintain, and update technical documentation, regulatory submissions, and product registrations to support market access and continued compliance in global markets.

• Interpret, assess, and communicate applicable regulatory requirements, standards, and guidance documents (e.g., EU MDR, FDA, ISO standards, and international regulations) to cross-functional teams in a clear and actionable manner.

Qualifications

• Bachelor's degree in Regulatory Science, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline

• Approximately 3-5 years of experience in Regulatory Affairs within the medical device industry.

• Strong knowledge of medical device regulatory requirements and processes, with experience supporting regulatory submissions, product registrations, technical documentation, or compliance activities.

• Understanding of Regulation (EU) 2017/745 (EU MDR), UK MDR, U.S. FDA requirements, and/or other international regulatory frameworks.

• Experience working within a regulated environment and ISO 13485 Quality Management System

• Experience contributing to technical documentation, change control activities, product development projects, or sustaining engineering initiatives.

• Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and apply them to practical business situations.

• Ability to manage multiple priorities effectively while maintaining a high level of accuracy and attention to detail.

• Strong written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams to build effective working relationships.

• Develop, maintain, and continuously improve regulatory procedures and processes to ensure ongoing compliance with applicable regulatory and quality management system requirements.

• Proactively identify regulatory risks, issues, and project roadblocks; analyze data to determine root causes and effectively communicate recommendations and mitigation strategies to project teams and management.

• Provide regulatory support for customer inquiries, product information requests, tender submissions, and other commercial activities as required.

• Support continuous improvement initiatives within Regulatory Affairs, Quality Management Systems, and broader business processes to enhance compliance, efficiency, and organizational effectiveness.

Salary range for this role: EUR 37,700.

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.

At BD, you’ll discover a culture in which you can learn, grow and thrive.

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.

Required Skills

Global Regulatory, Medical Device Regulations, Product Registrations, Regulatory Support

Salary Range Information

€37,700.00 - €60,350.00 EUR Annual

Primary Work Location

ESP Almaraz - Ctra. Nacional

Work Shift

At BD, you’ll 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. 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.