Regulatory Affairs Manager-Remote Job

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**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, ******
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. **** or ****
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 (**MEMBERS ONLY**SIGN UP NOW***.) 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.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

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