TransEnterix, Inc.

TransEnterix has a unique opportunity for a Regulatory Affairs Specialist to join our team and help bring an innovative surgical robotic system to global markets.  This Regulatory Affairs Specialist position will partner with cross-functional teams by providing regulatory guidance and support for post-market design and process improvement activities. This position will also support global product registration activities for TransEnterix medical devices.

Duties

  • Partner with cross-functional teams by providing regulatory guidance and support to product engineering for post-market design and process improvement activities
  • Review, assess, and provide regulatory approval for product or process changes 
  • Review and analyze technical protocols, data, and reports generated by various functional groups such as Product Engineering/R&D
  • Review and approve proposed labeling, packaging, and/or advertising and promotional materials in accordance with regulations and device-specific regulatory clearances/approvals
  • Prepare technical files and international product registration dossiers
  • Prepare establishment registrations, medical device listings, as well as obtain and maintain Certificates to Foreign Governments and Free Sale Certificates 
  • Engage global regulatory partners, when necessary, verbally and through written communications to discuss pending or new registrations, regulatory requirements, etc. 
  • Assist in preparing and/or authoring Premarket submissions, i.e. 510(k)'s, for surgical devices
  • Provide Regulatory Affairs support during internal and external audits
  • Keep current in regard to US and international medical device regulations and guidance documents
  • Assist in the development of best practices for Regulatory Affairs processes
  • All Other Essential Duties as directed

Qualifications 

  • Bachelor's Degree in engineering or a scientific discipline is required. A degree in biomedical engineering is preferred.
  • A minimum of 1 year of medical device Regulatory Affairs experience is required; 2-5 years of Regulatory Affairs experience is preferred.
  • A solid knowledge of US FDA regulations and Quality System requirements is required.
  • Experience preparing 510(k) submissions, medical device technical files, and international product registrations is preferred.
  • Experience interacting with global regulatory partners is preferred.
  • Excellent written, verbal communication, and presentation skills are required, including the ability to communicate clearly, concisely, and effectively verbally and in writing.
  • Ability to work as a member of a team in a timeline-driven environment with limited supervision.
  • Proven ability to handle multiple ongoing projects and tasks within required timelines.
TransEnterix, Inc.
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