Regulatory Affairs Director

3 days ago

HenleyinArden, United Kingdom BD Full time
Regulatory Affairs Senior Manager

BD is a global medical technology leader, and we're seeking a highly skilled Regulatory Affairs Senior Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our medical devices worldwide.

Key Responsibilities:
  • Prepare and document regulatory submissions to government agencies, including clearance, approval, and registration documentation.
  • Perform tasks associated with obtaining and maintaining product clearances, licenses, and registrations.
  • Lead pre-market and post-market activities, including 510(k) and EU technical file preparation.
  • Develop and monitor key performance indicators and provide regulatory expertise to cross-functional teams.
  • Mentor regulatory associates and ensure department processes and procedures are compliant and efficient.
Requirements:
  • Comprehensive knowledge of US, European, and international regulations and standards covering medical devices.
  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
  • Demonstrated organizational, planning, and program management skills.
  • Experience in continuous improvement projects, project management, and product development processes.
  • Excellent project management skills, with the ability to prioritize and delegate.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A comprehensive benefits package.

At BD, we're committed to advancing the world of health. If you're a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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