This position is no longer open for applications

Regulatory Affairs Manager-Remote!!!!

Regulatory Affairs Manager-Remote!!!! (LAC RegAffairs 2.24) Cincinnati, Ohio

**Experienced Regulatory Affairs Professional Opportunities

In Medical Device Industry**

Qualified Candidates will have a minimum of 2+ years hands-on experience with:

  • Authoring, maintaining and tracking dossiers for submission to Regulatory bodies:
    • FDA 510(k), EU, APAC, Health Canada, Latin America, etc.
  • Create regulatory documentation:  authorization letter, certifications, etc.
  • Experience in Quality Control, Systems, QA, Technology and laws and regulations     
  • Preparation, review, and completion of global regulatory strategies for establishing and maintaining quality system compliance to global regulations, directives and standards including FDA QSR, 93/42 EEC, ISO 13485, MDSAP, Health Canada, ANVISA, INMETRO, NMPA, and other countries in Latin America and the APAC region.

Qualified Candidates will:

  • Bachelor’s Degree required – Master’s Degree preferred
  • Experience in FDA and EU MDD/MDR, and other regulatory compliance requirements.
  • 2+ years of experience Regulatory Affairs within Medical Device Manufacturing
  • Effective verbal and written communicator.

Important to Know:

  • Must be able to work in the US without sponsorship
  • Full time position with benefits package
  • Remote work is available
  • Competitive Compensation and Benefits based on experience



***For more information on this opportunity or any others in the Medical Device Industry, contact Lindsey Croner directly at 605.367.6939**

Resumes may be confidentially emailed to 


Medical Device Companies:  If your team needs any position(s) filled, we can also assist in finding qualified talent.  Contact Lindsey directly

605.367.6939 or