Associate Director, Regulatory Affairs
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.
? Regulatory support of new and marketed Medical device products.
? Liaison with FDA and other regulatory agencies, as necessary, including arranging and attending face-to-face meetings.
? Prepare and provide advice on regulatory strategy and tactics and follow through to implementation, submission, and clearance/approval.
? Preparation of PMA Annual reports to FDA.
? Major contributor in product labeling reviews.
? Preparation and amendments/supplements for IDEs, new device applications, 510(k), PMAs, Technical Files, or Design Dossiers.
? Supportinternational product registrations.
? Understanding of the process of development and marketing of a device.
? Support Cross-Functional Project Teams and provide regulatory guidance.
? Maintain current knowledge of regulations and guidances and review impact on ZOLL products, disseminate information and potential strategies with teams.
? Identify and interface with other departments as necessary to implement corrective actions.
? Collect, analyze and disseminate department Key-Performance Indicators and metrics.
? Coordinate department responsibilities with other departments to ensure smooth workflow and timely completion of tasks.
? Participate in Engineering Change Order reviews.
? Must have excellent written and communication skills with the ability to interface well with management, internal multi-discipline staff, and FDA.
? Ability to put actions/projects in place to meet customers' expectations.
? Required computer skills include Word, Excel, PowerPoint.
? Must be able to multitask effectively and handle pressure.
? Must have had responsibility for regulatory affairs on project teams.
? Must have had liaison experience with FDA.
? Experience with Global collaborations is desired.
? Requires travel.
Required/Preferred Education and Experience:
? Bachelor's degree in a relevant s
cience is required. Advanced degreepreferred.
? A minimum of 8years experience in regulatory affairs (including FDA liaison), product development, and project management.
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 1990.