Regulatory Affairs Manager jobs in Allentown, PA

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.