Description

Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

Key Responsibilities:

Regulatory Submissions / Global Regulatory Submissions
FDA 510(K), PMA Submission
Medical Device Registration/Re-registration, Renewal
International Submission
Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia
Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
STED Preparation
Change submission, notifications
Regulatory licenses renewals
Regulatory Approbation
EU MDR Tech documentation Summary

IQ, OQ, PQ -Validation report
Risk documentation - Design and process
Manufacturing process and design controls
SAP - material and part creation and tracking
Very good written and oral communication in English.
Ease for reading/creating/modifying documents.
Able to work with minimal supervision. Self-motivated team player.

Adds Value:
RAC Certification: Medical Devices
 

Required Skills:

Must to have:
Regulatory Submissions / Global Regulatory Submissions
FDA 510(K), PMA Submission
Medical Device Registration/Re-registration, Renewal
International Submission
Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia
Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
STED Preparation
Change submission, notifications
Regulatory licenses renewals
Regulatory Approbation
EU MDR Tech documentation Summary

IQ, OQ, PQ -Validation report
Risk documentation - Design and process
Manufacturing process and design controls
SAP - material and part creation and tracking
Very good written and oral communication in English.
Ease for reading/creating/modifying documents.
Able to work with minimal supervision. Self-motivated team player.

Adds Value:
RAC Certification: Medical Devices

Good To Have
US and EU Submission
Worldwide regulatory agencies/authorities
CE Technical File / EU Technical File / Design Dossier
Support EU MDR Transition activities
EU MDR Gap Analysis
Collateral/Product specific IEC Standards Knowledge