Senior Manager, Regulatory Affairs, Medical Device

Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group. The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents. Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness.

Senior Manager, Regulatory Affairs, Devices

Job Summary

The Senior Manager, Regulatory Affairs, Devices, is responsible for assisting the Director of Regulatory Affairs, Medical Devices in the management of medical device regulatory compliance to global regulations and required standards, for Bracco Diagnostics Inc. medical device products and medical device combination products. This includes medical device products distributed in the United States, Canada, Europe, South America, Asia Pacific, the Middle East and Africa..

Main Responsibilities, Activities, Duties, and Tasks

• Assemble documentation for new medical device regulatory filings
  • Assemble and maintain 510(k) medical device submissions
  • Assemble and maintain European Technical Files
  • Assemble and maintain worldwide medical device product registrations
  • Author Global Regulatory Assessments for product changes
• File amendments globally and update files as necessary and update documentation in the medical device registration files as necessary, including but not limited to:
  • EU: updating Essential Requirements, Technical File Summary, Vendor and Component Information, Standards, Clinical Evaluation Documents,
  • Australia: updating Essential Principles and generation and maintenance of the Manufacturer Declaration
  • Canada: updating Canadian Compliance Checklists
  • Japan: working with the MAH in Japan to update registrations as required

• Communicate with manufacturers to obtain necessary information required for filings
• Track medical device renewal requirements

• • Obtain authorization for renewals
  • Track vendor establishment compliance certification for expiration and obtain new certificates

• File medical device renewals
• Track status of medical device registrations, and respond to requests for information from the FDA, Notified Body, or other Competent Authority
• Labeling:

• • Generate revised artwork in compliance with the regulations
  • Maintain and update the RA Labeling Tracker for status of all open label files and follow-up as required
  • Track label changes through the process
  • Provide finished artwork to suppliers and obtain proofs
• Generate and provide Certificates of Foreign Goods upon request

• Provide project planning in order to prospectively maintain regulatory compliance as relates to changes to the medical device compliance regulations or product changes in order to ensure that medical device registration dossiers, including U.S. 510(k)s and EU Technical Files are maintained and up to date.
• Prepare Global Regulatory Assessments regarding changes to medical devices and the need for regulatory submissions
• Generate and provide Certificates of Foreign Goods upon request.

• Presentation and training of BDI groups, affiliates and subcontractors regarding data and documentation requirements to support medical device registrations, including 510(k) submissions and EU Technical File assembly

• Tracking of medical device regulatory documentation status for signature
• Coordinating responses to medical device requests for information

Supervisory Responsibilities

• Not applicable

Education

• B.S. or B.A. degree in life sciences, engineering or chemistry curriculum.

Professional Experience, Knowledge & Technical Skills :

• At least five years of experience in medical device regulatory affairs
• A working knowledge and understanding of global Medical Device Regulations is required:
  • US regulatory affairs for medical devices and combination products;
  • Canadian and EU regulatory affairs for medical devices and combination products;
  • Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) in accordance with 21 CFR 820, and ISO 13485.
• General knowledge and understanding of regulatory affairs for medical devices for the rest of the world, including South America, the Middle East and Africa, and the Asia Pacific, is required.
• A working knowledge of the regulations and standards regarding design control and risk management is required.
• Excellent oral and written skills are required.

Bracco Diagnostics Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or any other protected status.