Regulatory Affairs Manager-Remote!!!! (LAC RegAffairs 2.24) Akron, 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 email@example.com
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 firstname.lastname@example.org
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.