Regulatory Compliance Specialist II

2 weeks ago

Covington, United States BD (Becton, Dickinson and Company) Full time

Position Overview:

As a Regulatory Affairs Specialist Level II, your primary focus will be on executing strategies for both domestic and international regulatory submissions while providing essential support to product project teams. This role necessitates a minimum in-office presence of three days per week.

About Our Organization:

At BD, we prioritize innovation. As one of the leading global medical technology companies, our mission is to enhance healthcare systems around the world. We are dedicated to designing, engineering, manufacturing, and marketing billions of medical technology products each year, transforming challenges into opportunities through groundbreaking solutions.

Become Part of Our Team:

We invite you to join us on our path of continuous improvement across our global teams. At BD, you will find an environment that fosters learning, growth, and the opportunity to realize your full potential. Together, we can create transformative possibilities.

Key Duties:

  • Offer regulatory guidance throughout product life cycles on project teams
  • Prepare and audit submissions, including 510(k)s, IDEs, and PMAs
  • Engage with regulatory authorities and address inquiries
  • Evaluate product labeling for regulatory compliance
  • Revise technical documentation for CE marking
  • Oversee associates within the Project Team

Required Qualifications:

  • Familiarity with U.S. and European medical device regulations
  • Excellent written and verbal communication abilities
  • Self-driven with the capability to work autonomously
  • Proficient in managing multiple projects simultaneously
  • Expertise in technical writing and regulatory submissions
  • Ability to maintain confidentiality

Educational Background and Experience:

  • Bachelor's degree in a scientific discipline with 3-5 years of experience in product registration, compliance, or quality systems
  • Regulatory Affairs Certification (RAC) is preferred

Why Work With Us?

Joining our team means being part of an organization that values your contributions, promotes authenticity, and supports your professional development. We are committed to integrity, accountability, and ongoing improvement. Together, we can reshape the future of healthcare and make a positive impact on the world.

Equal Opportunity Commitment:

We are an Equal Opportunity/Affirmative Action Employer committed to fostering diversity and inclusion. We oppose discrimination based on various factors and strive to create an inclusive workplace for everyone.

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