Director, Regulatory Affairs

Locations: Chelmsford, MA; Billerica, MA; San Jose, CA

Resuscitation

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Job Summary:

The 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 Senior Director, Regulatory Affairs. Manage 2-5 Regulatory Affairs Managers and 10-15 Regulatory Affairs Specialists/Associates.

Essential Functions:

  • 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/documentation (MDD & MDR) , or Design Dossiers (MDD) .

  • Support international 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.

Skills Requirements:

  • 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 science is required. Advanced degree preferred.

  • A minimum of 8 years' experience in regulatory affairs (including FDA liaison), product development, and project management.

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.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990