Regulatory Affairs Specialist

Role: Regulatory Engineer

Location: Mounds View, MN

Job Description:

• Assists the Regulatory Affairs Manager for ensuring compliance with the requirements set by the EU Medical Device Regulation and other regulatory bodies for Medical devices registration across different geographies
• Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
• Prepare and review the documentation required for Change submission, Notification , Re-registration of Medical devices
• Provide guidance to the offshore team in the preparation of documents for change submission, notification, re-registration packages of Medical Devices for regulatory agencies submission.
• Understands existing technical files / design dossiers/Technical documentation summary by reviewing documentation available for compliance to CE mark of EU and prepare the Country specific STEDs.
• 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.
• Maintains SOPs related to RA activity and suggests update of the QMS
• Review of deliverables as Regulatory expert ( STED and Country specific documentation)

Job Types: Full-time, Part-time, Contract

Salary: $50.00 – $55.00 per hour

Schedule:

• 8 hour shift

Experience:

• EU MDR: 2 years (Preferred)

Work Location: One location