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Associate Director of Regulatory Affairs

Associate Director of Regulatory Affairs

Job ID 
2018-1127
Job Locations 
US-MA-Chelmsford
Category 
Quality, Regulatory Affairs, and Service
Type 
Full-Time/Regular

More information about this job

Overview

The Associate Director of Regulatory Affairs is responsible for developing, implementing, and leading both regional and international regulatory strategy for ZOLL products, while representing the firm in various cross-functional project teams. Reports to Vice President, Quality Assurance and Regulatory Affairs. Manage 2-5 Regulatory Affairs Specialists and one Regulatory Affairs Manager.

Responsibilities

  • Regulatory support of new and marketed Medical device
  • Liaison with FDA and other regulatory agencies, as necessary, including arranging and attending face-to-face
  • Prepare and provide advice on regulatory strategy and tactics and follow through to implementation, submission, and clearance/approval.
  • Preparation of PMA Annual reports to
  • Major contributor in product labeling
  • Preparation and amendments/supplements for IDEs, new device applications, 510(k), PMAs, Technical Files, or Design
  • Support international product
  • Understanding of the process of development and marketing of a
  • Support Cross-Functional Project Teams and provide regulatory
  • Maintain current knowledge of regulations and guidances and review impact on ZOLL products, disseminate information and potential strategies with
  • Identify and interface with other departments as necessary to implement corrective
  • Collect, analyze and disseminate department Key-Performance Indicators and metrics.
  • Coordinate department responsibilities with other departments to ensure smooth workflow and timely completion of
  • Participate in Engineering Change Order

 

Qualifications

  • Must have excellent written and communication skills with the ability to interface well with management, internal multi-discipline staff, and
  • Ability to put actions/projects in place to meet customers'
  • Required computer skills include Word, Excel,
  • Must be able to multitask effectively and handle
  • Must have had responsibility for regulatory affairs on project teams.
  • Must have had liaison experience with FDA. 

 

Required/Preferred Education and Experience:

 

  • Bachelor's degree in a relevant science is required. Advanced degree preferred.
  • A minimum of 8 years experience in regulatory affairs (including FDA liaison), product development, and project

 Other Duties:

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

 

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of l 990