Senior Regulatory Affairs Specialist - REMOTE

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Job description

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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 temporary 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. This position will support EU MDR efforts and is anticipated to last approximately through September 2024. This position is a remote role.

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.

Employment at BD is contingent upon the Company's receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do 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. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates.

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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.

Primary Work Location
USA NJ - Franklin Lakes

Additional Locations

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