Medical Device, Quality/Risk Management, Submission & Registration, Worldwide Regulatory Affairs
4 Year Degree
TransEnterix is seeking a Regulatory Affairs Manager to lead our top-notch US Regulatory team. This is an exciting time to join TransEnterix! This is a unique opportunity to be an important part of surgical robotics technology and join a leading edge team in the forefront of Digital Laparoscopy.
The Regulatory Affairs Manager is responsible for leading a team in gaining global market entry and maintaining global regulatory compliance for the company's products. This role will devise regulatory strategies to maximize efficiency of resources and time. Success in this role requires deep product and regulatory knowledge in order to make decisions independently. This role is responsible for direct management of the US Regulatory team and influence management over regulatory teams globally.
Manage the regulatory team to a high level of engagement and customer (internal and external) satisfaction.
Oversee and supervise 510(k) submissions to US FDA for medical devices as well as international submissions
Must be able to "do" as well as "lead". Take on a share of submission and compliance work to better understand challenges and devise meaningful process efficiencies.
Partner with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning for 510(k) submissions, CE marking and international product registrations
Interprets regulations and provides regulatory guidance to global teams
Review technical protocols, data, and reports generated by other departments or test facilities and analyzes for alignment with international standards and regulations
Engages FDA regulators, verbally and through written communications to discuss pending or new submissions, regulatory requirements, etc.
Leads development of on-product labeling; advises and approves advertising and promotional materials in accordance with regulations and device-specific regulatory clearances/approvals
Provides Regulatory Affairs support during internal and external audits
Provides Regulatory leadership on expansion into new geographic markets
Keeps current in regard to US and international medical device regulations, guidance documents and international standards
Develops best practices for Regulatory Affairs processes
All Other Essential Duties as directed
Bachelor's Degree in engineering, scientific discipline or related field
Minimum of 10 years of Regulatory Affairs experience
Minimum of 7 years' experience in regulatory working on complex medical devices
Demonstrated experience leading and developing a team
Experience with surgical medical devices is preferred
Experience preparing 510(k) submissions or PMA submissions for medical devices
Successful track record of 510(k) submissions for devices containing software components
Experience interacting with US FDA and Notified Body personnel is required
A solid knowledge of US FDA regulations and Quality System regulations
Experience preparing CE technical files according to STED format
Global regulatory Affairs experience required experience working in Asia is a plus
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 independently and as leader in a fast-paced environment
Regulatory Affairs Certification (RAC) preferred
Internal Number: RAMGR01
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 in today’s value-based healthcare environment.
The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control.
At TransEnterix, you have the opportunity to make your mark in reshaping healthcare worldwide.