Regulatory Affairs Specialist

Full Time
Fridley, MN 55432
Posted
Job description

Role: Regulatory Engineer

Location: Fridley, 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 Type: Contract

Salary: $60.00 - $65.00 per hour

Schedule:

  • 8 hour shift

Ability to commute/relocate:

  • Fridley, MN 55432: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: One location

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