Regulatory Engineer/Regulatory Specialist Job
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Employer: Sandy Steve
SpiderID: 14232482
Location: Mounds View, Minnesota
Posted: 9/1/2026
Wage:
Priority Review Date: 10/1/2026
Job Code / NOC / SOC:
Category: Medical/Health
Job Description:
Regulatory Engineer/Regulatory Specialist
Location: Mounds View, MN
Onsite Position
Key Responsibilities:
• Product Registration Support- APAC, LATAM as per the assigned countries
• Prepare and review the documentation required for Renewal/Change submission/Notification/Re-registration of Medical devices
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo RAs
• Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.
• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information.
• Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
• Maintains information systems (electronic and paper) for regulatory information and reports.
• Oversee and ensure maintenance of regulatory licenses renewals on timely manner
• Clearly conveys information to peers, supervisors and other stakeholders
• Supports the development of internal RA systems and procedures.
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:
• Regulatory submission experience for Electromechanical Class IIB and Class III devices
• RAC Certification: Medical Devices
• FDA 510(K), PMA Submission
• Collateral/Product specific IEC Standards Knowledge
• Support EU MDR Transition activities
• EU MDR Gap Analysis
Preferred Skillset(s) :
• Knowledge in geography specific regulatory requirements for medical devices (APAC, LATAM.)
• Experience in Class III implants
Location: Mounds View, MN
Onsite Position
Key Responsibilities:
• Product Registration Support- APAC, LATAM as per the assigned countries
• Prepare and review the documentation required for Renewal/Change submission/Notification/Re-registration of Medical devices
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo RAs
• Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.
• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information.
• Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
• Maintains information systems (electronic and paper) for regulatory information and reports.
• Oversee and ensure maintenance of regulatory licenses renewals on timely manner
• Clearly conveys information to peers, supervisors and other stakeholders
• Supports the development of internal RA systems and procedures.
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:
• Regulatory submission experience for Electromechanical Class IIB and Class III devices
• RAC Certification: Medical Devices
• FDA 510(K), PMA Submission
• Collateral/Product specific IEC Standards Knowledge
• Support EU MDR Transition activities
• EU MDR Gap Analysis
Preferred Skillset(s) :
• Knowledge in geography specific regulatory requirements for medical devices (APAC, LATAM.)
• Experience in Class III implants
Contact Information:
| Contact Name: Sandy Steve | Type: Recruiter |
| Company: |