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 firstname.lastname@example.org
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 email@example.com