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Join to apply for the Senior Regulatory Specialist role at Argon Medical Devices, Inc.

Join to apply for the Senior Regulatory Specialist role at Argon Medical Devices, Inc.

Position Overview
This position authors regulatory submissions and technical documentation to support OUS markets as well as organizes regulatory information and tracks/controls submissions. Reviews and provides recommendations on labeling for compliance with regulatory filings. Performs reviews of product changes for impact on regulatory filings worldwide.

Position Overview
This position authors regulatory submissions and technical documentation to support OUS markets as well as organizes regulatory information and tracks/controls submissions. Reviews and provides recommendations on labeling for compliance with regulatory filings. Performs reviews of product changes for impact on regulatory filings worldwide.
What You Will Do

• Provide regulatory guidance to colleagues to ensure subsequent documentation will meet the needs of the regulatory submissions.
• Prepare European technical documentation and other OUS license applications.
• Lead project for gap remediation with a cross functional team.
• Prepares and submits filings.
• Maintain regulatory files/database and chronologies in good order.
• Establish and maintain system for tracking changes in documents submitted to agencies or partners.
• Review labeling and labels for compliance with regulatory requirements.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
  

• Bachelor's degree in science, math or engineering discipline required.
• 5+ years relevant experience in FDA regulated industry.
• Experience and knowledge within medical device industry (disposable devices preferred).
• Knowledge of international regulatory requirements applicable to medical devices.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong attention to detail and ability to manage multiple projects simultaneously.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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