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.
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
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 is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options.