Regulatory Affairs Specialist
Aforce solutions
St Paul
regulatory
regulatory
engineer
ra
regulatory submissions
medical
mdr
technical
apac
latam
china
russia
japan
November 19, 2022
Aforce solutions
St Paul
FULL_TIME
*Role: Regulatory Affairs Specialist*
*Location: Mounds View, MN*
*Job Description: *
Regulatory engineer, Regulatory Specialist, RA Specialist or RA Engineer
*Must to have: *
Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
Regulatory Submissions / Global Regulatory Submissions/ International Submission
Medical Device Registration/ Re-registration/ Regulatory licenses renewals
Change submission, notifications
STED Preparation
Regulatory Approbation
EU MDD/MDR Tech documentation Summary
Notified Body
CE Technical File / EU Technical File / Design Dossier
*Adds Value*:
RAC Certification: Medical Devices
FDA 510(K), PMA Submission
Collateral/Product specific IEC Standards Knowledge
Support EU MDR Transition activities
Job Types: Full-time, Contract
Salary: $60.00 - $65.00 per hour
Schedule:
* 8 hour shift
Ability to commute/relocate:
* Mounds View, MN 55112: Reliably commute or planning to relocate before starting work (Preferred)
Work Location: One location
*Location: Mounds View, MN*
*Job Description: *
Regulatory engineer, Regulatory Specialist, RA Specialist or RA Engineer
*Must to have: *
Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
Regulatory Submissions / Global Regulatory Submissions/ International Submission
Medical Device Registration/ Re-registration/ Regulatory licenses renewals
Change submission, notifications
STED Preparation
Regulatory Approbation
EU MDD/MDR Tech documentation Summary
Notified Body
CE Technical File / EU Technical File / Design Dossier
*Adds Value*:
RAC Certification: Medical Devices
FDA 510(K), PMA Submission
Collateral/Product specific IEC Standards Knowledge
Support EU MDR Transition activities
Job Types: Full-time, Contract
Salary: $60.00 - $65.00 per hour
Schedule:
* 8 hour shift
Ability to commute/relocate:
* Mounds View, MN 55112: Reliably commute or planning to relocate before starting work (Preferred)
Work Location: One location
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