Regulatory Affairs Specialist

5 days ago

Franklin, Wisconsin, United States Extremity Care Full time
Job Description

At Extremity Care, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs Department, you will play a pivotal role in ensuring compliance with regulatory requirements for our innovative medical products.

Key Responsibilities:

  • Regulatory Strategy: Develop and implement a comprehensive regulatory program to ensure product approval and adoption within the US and select international markets.
  • Regulatory Intelligence: Conduct in-depth research to determine requirements and develop plans for compliance with domestic and international regulations.
  • Submission Preparation: Plan, prepare, and submit regulatory documents for product registrations, including IDE, 510(k), and PMA submissions.
  • Compliance Reporting: Generate and coordinate necessary reports to ensure regulatory compliance.
  • Active File Maintenance: Maintain accurate and up-to-date records for all registered products.
  • Labeling Review: Review product labeling for regulatory compliance and propose updates as necessary.
  • Database Management: Maintain a comprehensive regulatory intelligence database.
  • Procedure Authoring: Author and revise procedures according to FDA, AATB, and other relevant regulations.
  • Regulatory Documentation: Prepare and submit regulatory documents for FDA/AATB reportable events.
  • Submission Assistance: Assist with regulatory submissions for TRG letters, Requests for Designation (RFD), and Pre-RFD.
  • FDA Registrations: Complete submissions and updates for FDA registrations.
  • State Licensing: Manage state license application submissions and renewals.
  • Project Support: Support new projects and product development by reviewing validation protocols to ensure regulatory compliance.
  • Regulatory Knowledge: Maintain expertise in FDA 21 CFR 820, cGMP, FDA 21 CFR 1271, AATB standards, cGTP, and other relevant policies and procedures.
  • Record Keeping: Maintain accurate and up-to-date records according to Standard Operating Procedures.
  • Additional Duties: Perform other duties as assigned to support the Regulatory Affairs team.

Requirements:

  • Education: Bachelor's Degree in a biological or health-related field. A graduate degree in a related field is preferred.
  • Experience: Minimum of 5 years in medical device submission preparation with proven experience as a primary submission owner preferred.
  • Regulatory Knowledge: Comprehensive understanding of US medical device regulations, standards, and guidance documents, with international regulatory submissions experience considered a plus.
  • Specialized Expertise: Experience in the HCT/Ps regulatory space is an added advantage.

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