Job Description Summary

This Regulatory Affairs' Specialist will be a temporary 6 month assignment.

Within the BDM-PS Regulatory Affairs team, the associate will be responsible :

• To assist RA core team members with submission of file
• To manage maintenance of existing files
• To lead and execute the implementation of given actions for EU MDR compliance
• To actively participate to the process of management of new/revised regulation/standards

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.

Duties and Responsibilities:

Management of RA files

• Assist the RA core team member with submission of file

• Provides regulatory assessment on change request, approves relevant ECRO, updates files upon needs, and notifies authorities as applicable.

• Manage authorities inquiries

• Update BD system with relevant Regulatory information regarding files

Lead and execute implementation of given action for EU MDR compliance

• Collect and gather data (UDI/product data/IFU) to be uploaded in BD system for future transfer to authorities database

Management of new/revised standards/regulations

• Watches relevant sources of regulatory requirements, analyse gap and potential impact, share outputs within the business

• Support the business with implementation of coming improvement to the process

Minimum Qualifications:

• Bachelor’s degree from a four-year college or university in Regulatory Affairs or Quality Management Systems and 2 years of relevant experience in Medical devices or Pharmaceutical Industry OR Minimum of 4 years of relevant experience

• Fluid in English (I put this because the second location for the position is in France, and English is a must if hiring in France)

• Ability to work in a collaborative team environment

For many 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, weekly testing for COVID-19 may be available instead of vaccination. 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.

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

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.

PDN

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

FRA Le Pont-de-Claix Cedex

Work Shift