Becton Dickinson (BD) is hiring a Regulatory Affairs Specialist

BD is hiring a Regulatory Affairs Specialist to prepare regulatory submissions for new or modified medical devices in the U.S., Europe, and global markets. You will ensure product development aligns with business objectives and represent Regulatory Affairs within cross-functional design teams.

What You'll Do

• Prepare regulatory submissions required to market new or modified medical devices in the U.S., Europe, and other global markets.
• Prepare technical files and summaries of technical documentation (STED) for CE marking.
• Submit notification to the European Notified Body regarding significant changes.
• Review and approve labeling, promotional and advertising materials as well as clinical protocols to ensure regulatory compliance.
• Represent Regulatory Affairs in design teams and projects by providing regulatory guidance throughout the product development cycle.
• Coordinate team inputs for regulatory submissions.
• Support International Registrations as it relates to product changes and/or new product launches.

What We're Looking For

• Minimum bachelor's degree.
• Minimum 3-5 years of regulatory affairs experience, preferably in the medical device industry.

Nice to Have

• Proven experience with regulatory affairs systems such as Veeva preferred.

Benefits & Compensation

• Compensation range: $106,600.00 – $175,900.00 USD Annual.
• A culture that values your opinions and contributions, encourages you to bring your authentic self to work, helps each other be great, does what’s right, holds each other accountable, and learns and improves every day.
• A culture in which you can learn, grow, and thrive.

Work Mode

This is a hybrid role based in Franklin Lakes, NJ, USA.

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.