Regulatory Affairs Director

2 months ago


Lincolnshire, Illinois, United States Jacobs Management Group Full time
Senior Manager, Regulatory Affairs

At Jacobs Management Group, we're seeking a seasoned Senior Manager to lead our regulatory affairs efforts. As a key member of our team, you'll be responsible for shaping our regulatory strategies and ensuring compliance with FDA and Health Canada regulations.

Key Responsibilities:
  • Develop and implement regulatory strategies for medical devices.
  • Collaborate with cross-functional teams to drive product success.
  • Manage and mentor a team of regulatory affairs professionals.
  • Provide regulatory guidance on product development and marketing strategies.
  • Oversee regulatory procedures and implement continuous process improvements.
Requirements:
  • 7+ years of progressive experience in regulatory affairs.
  • Must have experience with in vitro diagnostics (IVDs).
  • Thorough understanding of FDA, Health Canada regulations, and the 510(k) process.
  • Expertise in Hematology, Urinalysis, Flow Cytometry, and Coagulation is a plus.
  • Ability to communicate complex scientific data effectively.
  • Proven leadership skills with experience in team management.
What We Offer:
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

We're excited to hear from you Please submit your application, and we'll be in touch to discuss further.