Job Description Summary

Job Description

We are the makers of possible

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 creativity 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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

This position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors. May provide leadership by assigning work and resolving complex problems.

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 2024.

Responsibilities:

1. Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance.

2. 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.

3. Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.

4. Submit notification to the Notified Body about significant changes to CE marked products in a timely manner.

5. Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.

6. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.

7. Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.

8. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.

9. Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.

10. Submit product listing to the FDA when deemed necessary.

11. Support International Registrations as it relates to product changes and/or new product launches

12. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.

13. Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.

Ability to work with minimal supervision

Minimum Requirements:

• B.S. degree or higher in a technical subject area, preferably in computer science, engineering, bioengineering, biology, or chemistry.

• 1 - 3 years Regulatory Affairs experience in medical device companies.

Preferred Qualifications:

• Proficient in using Microsoft Word, Excel and PowerPoint.

• Strong communication and project management skills.

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

• 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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be phenomenal, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 aim to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

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