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.

Job Description

Job Responsibilities

• Identify, submit and maintain regulatory information in Regulatory databases.
• Manage Notification of Change (NoC) in RIM system. Create NoCs, route for region / country impact assessment, track RA project requirements, link evidence of completion, and complete final RA documentation for project closure.
• Support RIM system changes including system configuration decisions, workflow design, data migration, and on-boarding new users.
• Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
• Assess necessity for notification to the Notified Body about significant changes to CE marked products in a timely manner. Prepare documentation updates for non-significant changes in a timely manner.
• Complete, review/ approve documentation to ensure regulatory compliance.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary to update Regulatory documentation.
• Submit regulatory information on products to external databases when deemed necessary.
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
• Coordinate and respond to requests for product data and information.

Education and Experience

Education: B.S. degree or higher in a technical discipline, preferably in computer science, engineering,

bioengineering, biology, or chemistry.

Experience: 2-4 years Regulatory Affairs experience in medical device companies including international

product registrations, new product development and sustaining engineering.

Knowledge and Skills

Knowledge:

· Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC and working knowledge of

21 CFR 820 -Quality System Regulation and working knowledge of standards and FDA guidance’s.

· Working knowledge of all material related regulatory requirements (e.g., Prop 65, CONEG, DOT,

IATA, IMO, OSHA, etc.) in the US, Europe, and Canada.

Skills:

· Proficient in using Microsoft Word, Excel and PowerPoint.

· Proficient in English

· Strong communication Skill, both oral and written

· Strong project management skills

· Must be able to handle multiple tasks and attention to detail.

· Self-motivated, comfortable with working with people remotely

· Organized, analytical thinker with attention to details

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 visithttps://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

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