Regulatory Affairs Specialist

Becton Dickinson; Köttelbach; Vor Ort; EUR 59.000 - 89.000; Vollzeit

Zusammenfassung

Becton, Dickinson, and Company is seeking a Regulatory Affairs professional to develop and execute regulatory strategies for Pharmacy Automation products in Germany. The role involves assessing pathways, guiding product development, and ensuring compliance with CE marking and EU machinery regulations.

You will review technical files, support country-specific registrations, and collaborate with cross-functional teams across a global organization.

Qualifikationen

• Bachelor’s or Master’s degree in medical engineering, medical technology, or a related engineering/science field.
• Experience in regulatory affairs for medical devices or regulated technical products.
• Proficiency in German and English, written and spoken.

Aufgaben

• Develop and execute regulatory strategies for Pharmacy Automation products.
• Assess regulatory pathways, requirements and risks for products.
• Provide regulatory guidance during product development and lifecycle activities.
• Support CE marking and compliance with EU machinery directives/regulations.
• Review and approve technical files, declarations and documentation.
• Perform regulatory impact assessments for changes and determine actions.
• Identify country-specific requirements, registrations and market access activities.
• Review marketing materials to ensure regulatory compliance.

Kenntnisse

Regulatory strategies

Regulatory affairs

CE marking

German proficiency

English proficiency

Medical devices

Ausbildung

Bachelor’s or Master’s degree

Medical engineering

Engineering discipline

Jobbeschreibung

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.

Responsibilities:

• Develop and execute regulatory strategies;
• assess applicable regulatory pathways, requirements, and risks for Pharmacy Automation products.
• Provide regulatory guidance throughout product development and product lifecycle activities.
• Support CE marking and compliance with applicable EU machinery legislation, including the transition from the Machinery Directive to the Machinery Regulation.
• Provide regulatory oversight and review of Technical Files, declarations, and technical documentation.
• Perform regulatory impact assessments for product and process changes and determine required regulatory actions.
• Identify and support country-specific requirements, registrations, certifications, and worldwide market access activities.
• Review and approve, as applicable, Ad/Promo materials, product claims, labeling, sales literature, and Marketing communications to ensure claims are supported, accurate, and compliant.
• Monitor regulatory and standards developments and support cross-functional teams, audits, inspections.

Requirements:

• A bachelor’s or master’s degree is required, preferably in medical engineering, medical technology, or other engineering, technical, or scientific discipline relevant to medical devices or machinery Relevant Regulatory Affairs experience in medical devices or other regulated technical products Professional proficiency in written and spoken German and English is required

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 DEU Kelberg - Rowastrasse Additional Locations DEU Frankfurt - Walther-von-Cronberg-Platz

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 €58 500,00 - €89 250,00 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. Join our company and see how you can become a part of one global mission to make a difference in human health.