Regulatory Affairs Specialist

BD; North Carolina; Vor Ort; USD 66.000 - 100.000; Vollzeit

Zusammenfassung

BD is a leading global medical technology company, advancing healthcare worldwide. We seek a Regulatory Affairs professional to develop regulatory strategies for Pharmacy Automation products and support CE marking across EU machinery regulations, while coordinating international market access.

Strong German and English communication skills are required. The role involves guidance throughout product development and lifecycle, oversight of technical documentation, and collaboration with

Qualifikationen

• Regulatory affairs experience in medical devices or regulated technical products.
• Proficiency in written and spoken German and English.

Aufgaben

• Develop and execute regulatory strategies; assess applicable regulatory pathways, requirements, and risks for Pharmacy Automation products.
• Provide regulatory guidance throughout product development and lifecycle activities.
• Support CE marking and compliance with EU machinery legislation, including transition from Machinery Directive to 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 Ad/Promo materials, product claims, labeling, sales literature, and Marketing communications for compliance.
• Monitor regulatory and standards developments and support cross-functional teams, audits, inspections.

Kenntnisse

Regulatory Affairs

German & English proficiency

Ausbildung

Bachelor’s or Master’s degree in medical engineering/medical technology/related field

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

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

€58 500,00 - €89 250,00 EUR Annual