Regulatory Affairs Specialist

BD; Durham (NC); On-site; USD 66,000 - 100,000; Full time

Job summary

BD is seeking a Regulatory Affairs professional to advance regulatory strategies for Pharmacy Automation products in Germany. You will guide product development to ensure CE marking and compliance with the Machinery Regulation, review technical documentation, and support market access globally.

Requirements include a bachelor’s or master’s degree in medical engineering or related field, plus regulatory experience in medical devices and fluent German and English.

Qualifications

• Regulatory affairs experience in medical devices.
• Degree in medical engineering or related field.
• Proficiency in written and spoken German and English.

Responsibilities

• Develop and execute regulatory strategies for Pharmacy Automation products.
• Provide regulatory guidance throughout product development and lifecycle.
• Support CE marking and EU machinery regulation compliance.
• Oversee Technical Files, declarations, and documentation.
• Assess regulatory changes and determine required actions.
• Identify country-specific requirements and worldwide market access.

Skills

Regulatory affairs

Medical devices

German language

English language

Education

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

Job description

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.

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.

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