Advanced Regulatory Affairs Manager

2 weeks ago


Franklin, Wisconsin, United States Extremity Care Full time
Extremity Care: Senior Regulatory Affairs Specialist

Extremity Care is seeking a Senior Regulatory Affairs Specialist to oversee the adherence of cutting-edge medical products to regulatory standards. The successful candidate will possess a strong background in regulatory strategies and will be instrumental in facilitating regulatory achievements in both domestic and global markets.

Key Responsibilities:

  • Develop and implement a thorough regulatory framework for product approvals
  • Conduct regulatory research to inform compliance strategies
  • Prepare, submit, and manage regulatory filings
  • Create essential reports for compliance documentation
  • Maintain current records for registered products
  • Evaluate product labeling for regulatory adherence
  • Manage a regulatory intelligence database
  • Draft and update procedures in accordance with regulations
  • Prepare regulatory documents for significant events
  • Assist in regulatory filings and product registrations
  • Oversee state licensing applications and renewals
  • Support new initiatives and product innovation
  • Stay informed on relevant regulatory changes
  • Organize and maintain records in compliance with standard operating procedures
  • Perform additional responsibilities as required

Skills & Abilities:

  • Outstanding organizational capabilities
  • Proficient in managing multiple tasks simultaneously
  • Excellent verbal and written communication skills
  • Strong analytical and problem-solving skills
  • Skilled in research and data analysis

Education & Experience:

  • Bachelor's Degree in a biological or health-related discipline
  • At least 5 years of experience in preparing medical device submissions
  • Thorough understanding of US medical device regulations
  • Experience in the HCT/Ps regulatory area is advantageous


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