Employment - Regulatory Affairs Manager

Purpose of Job:

Increase the bandwidth of the Regulatory Affairs department to aid the group in meeting the corporate objectives of TransWorld Med. This position will support these objectives by assisting in product development teams, performing product registrations, and assuring regulatory compliance.

Major Duties and Primary Responsibilities:

  • Representing Regulatory Affairs on and providing regulatory guidance to project teams regarding: designing, developing, evaluating and commercializing medical devices.
  • Coordinating, compiling, submitting, and processing approval submissions for clinical evaluation or commercialization.
  • Compiling, submitting, and processing approval submissions for export approval/certification.
  • Compiling and submitting device experience reports required to be submitted in accordance with FDA Medical Device Reporting System, the EU Device Vigilance System, and the reporting system of any other applicable venue.
  • Participating in third party audits (FDA, State of California, Notified Body) of the Quality Management System, and assisting with coordinating, compiling, and submitting responses to any observations made during those audits.
  • Review and approval of documentation for regulatory compliance.
  • Support the resource planning, development, execution, and documentation of all regulatory filings or marketing initiatives.
  • Perform audits / reviews.
  • Support oral and written presentations of clinical results by study investigators.
  • Attend scientific sessions and symposia, and summarize relevant posters and presentations.
  • Demonstrate strong interpersonal skills and ability to independently confront issues for a win-win outcome.

Job Requirements:

Bachelor's Degree and a minimum of 5 years of increasingly responsible industry experience (including a minimum of 3 years' experience in pharmaceutical development or drug delivery), or equivalent combination of education and experience.

Extensive knowledge of CMC requirements. Knowledge of and competence in application of CFRs (210/211 and 820), and ICH Guidelines. Advanced computer skills specifically in Microsoft Word, Excel and Adobe Acrobat. Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences. Strong team leadership experience and motivational skills.

Interested candidates should submit their resumes via email.