Description

Responsible for managing the regulatory affairs activities throughout the organization. Manages and compiles regulatory submissions in the USA, EU and other jurisdictions as required. 

Requirements

• Manage and implement regulatory affairs processes to ensure compliance with FDA QSR, ISO 13485, MDR 2017/745, MDSAP, and other regulatory requirements in accordance with company goals.
• Manage and compile pre-market notifications for the US FDA (Traditional 510k and Special 510k) and letters to file.
• Manage and participate in the compilation of documents as needed for product registrations, licensing, and notifications to be submitted to regulatory authorities, notified bodies, authorized representatives, and MDSAP countries.
• Participate in the compilation of Technical Documentation Files for submission toward certification to the EU Medical Device Regulation (MDR 2017/745).
• Coordinate responses to requests from customers and suppliers for regulatory information.
• Coordinate legalization of documents such as certificates to Foreign Governments, etc.
• Assists with FDA inspections and other external audits.
• Review of ECNs and product labeling, packaging, advertising, and promotional information.
• Serves as a team member on new product development teams, aids in the development of regulatory strategies, and compiles documents for inclusion in design history files. 
• Organizes regulatory files in pdf and paper format. 
• Interacts with personnel from organizations to achieve department and company goals. 
•  Attention to detail, written and oral communication skills, analytical ability, and computer literacy. 

Education/Experience

Bachelor’s Degree preferred.

Minimum of 7 years of medical device experience preferably in Quality or Regulatory Affairs.