Regulatory Affairs Specialist (m/f)

  • Bachelor of Science Degree in related field e.g. Microbiology, Biology or other sciences
  • Must have a minimum of 5+ years of experience in a regulated industry (e.g., medical devices, pharmaceuticals, etc.). Regulatory Affairs experience is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
  • Ability to develop SOPs and guidance documents using good technical writing practices
  • Demonstrated knowledge in Quality System Regulations / Good Manufacturing Practices
  • Assists in the completion and assembly of regulatory submissions (both international and domestic)
  • Maintains regulatory files including submissions, technical files, etc.
  • Assists in regulatory body (including Notified Body and FDA) internal & customer audits, product recalls, Vigilance, MDR reportability, as necessary
  • Interfaces with customer service and engineering on customer complaints and complaint investigations
  • Ensures customer complaints, MDR's and global vigilance reporting are addressed in a timely manner according to the risk level per company and regulatory standards
  • Assists customer service and quality team in improving the customer complaint process and procedures
  • Management of domestic and international Standards, directives, regulations, etc. for gap analysis according to the latest revision
  • Assist in the internal & external audits
  • Independently handle problems that arise within area of responsibility
  • Able to assist Freudenberg Medical departments in gathering data or special assignments with limited assistance
  • Performs in-depth review of regulatory data / information and provide oversight of query resolution and database to Supervisor
  • Able to change priorities when directed by Supervisor / Manager
  • Interacts effectively with other employees within the department and the company

» Job description

Freudenberg Medical
Carpinteria, CA [USA]

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