Regulatory Affairs Specialist

BD; San Agustín del Guadalix; Sur place; EUR 36 000 - 39 000; Plein temps

Résumé du poste

Becton Dickinson is seeking a Regulatory Affairs Specialist to contribute to regulatory strategy and submission activities for medical devices. The role focuses on MDR compliance, international registrations, and maintaining technical documentation throughout the product life-cycle.

You will lead regulatory assessments, support audits by authorities, and collaborate with cross-functional teams to ensure timely approvals and certifications across markets.

Qualifications

• 2–3 years experience in regulatory affairs within the medical devices industry.
• Knowledge of MDR CE marking and regulatory requirements.
• Experience with NB audits / communications.
• Familiarity with ISO 7864, ISO 7886, ISO 6009, ISO 9626, ISO 62366, ISO 14971 and ISO 13485.
• Experience with Design Control, Risk Mgmt, and V&V processes.

Responsabilités

• Participation in cross-functional product development teams as the regulatory lead.
• Development of regulatory strategies for product release and change assessments.
• Review of labeling, claims, changes, and complaints to determine required regulatory actions and ensure compliance.
• Attend audits to represent RA positions and processes.
• Create, maintain and update product Technical Files.
• Coordinate international registrations and monitor progress by country requirements.
• Assess regulatory changes and determine impact on products.
• Prepare regulatory documentation for customs release.
• Prepare regulatory dossiers for Health Authorities and maintain them through lifecycle.

Connaissances

Regulatory affairs

Medical devices

MDR compliance

ISO standards

English (fluent)

Description du poste

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 its 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 has to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations, also identifying, preparing and collecting data needed to acquire and maintain certifications and commercialization authorizations of BD products.

The function is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards.

Main responsibilities will include:

• Participation in cross-functional product development teams as the regulatory lead.
• Development of regulatory strategies for product release and product change assessments.
• Participate to the review of process/product changes, labeling, claims, product complaints, etc., to determine the need for any regulatory activities and to ensure compliance to Medical Devices regulations.
• Attends to audits performed by internal and external authorities to represent RA positions and processes.
• Creation, maintenance and updates of products Technical Files.
• OUS international product registrations attending to individual country specific requirements; monitor and report progress.
• Assesses changes in regulations and helps to determine their impact.
• Prepare about regulatory documentation process for customs release process.
• Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.

About you

• 2 - 3 years experience in regulatory affairs within the medical devices technology industry.
• Compliance experience with Class I/IIa/III products under MDR.
• Have knowledge of the regulatory framework pertaining to Medical Devices such MDR CE Marking.
• Experience with NB audits / communications.
• Experience working with International Standards in particular ISO 7864, ISO 7886, ISO 6009, ISO 9626, 62366(usability), ISO 14971 and ISO 13485.
• Good working knowledge of Design Control, Risk Mgmt, V&V processes.
• Proven knowledge and material experience in International registrations/ approval process for medical devices.
• Fluent in English as you will be working in an international environment.
• Proven computer skills.
• You should be an enthusiastic teammate, able to participate with commitment and sense of ownership in highly qualified teams, in a complex and fast evolving environment.

Salary range for this role: EUR 36.000 - EUR 39.000

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 will 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.

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 Optional Skills

Primary Work Location ESP San Agustin del Guadalix

Additional Locations Work Shift

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. 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 €32,700.00 - €52,350.00 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. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all.