Principal Regulatory Affairs Specialist

Locations: Chelmsford, MA; Remote, 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:

Principal Regulatory Affairs Specialist is responsible for providing strong leadership in the timely completion of all worldwide regulatory activities relating to product approval and compliance, including interfacing with regulatory agencies such as the FDA, Notified Bodies, Competent Authorities, and other global regulatory authorities. Further responsibilities include support of the Engineering and Quality teams, providing guidance and serving as a resource in the development and implementation of product development, CAPA, internal audit and vendor/supplier audit programs.

Essential Functions:

  • Provide regulatory guidance to the company to identify risks and opportunities as they relate to worldwide business operations

  • Interpret regulations, laws, and guidance and establish, implement and monitor policies, procedures and processes to ensure compliance

  • Review product development and design intent to assure regulatory requirement compliance

  • Review/approve engineering change orders to ensure regulatory requirement compliance

  • Review/approve marketing materials, labels and labeling for regulatory requirement compliance

  • Review/approve product verification and validation test plans regulatory requirement compliance

  • Participate in regulatory inspections/audits by internal and external audit authorities

  • Comply with company policies and procedures regarding Employee health, safety, and conduct.

  • Travel: 10% of time

Skills Requirements:

  • Excellent analytical and communication skills, ability to manage complex problems/projects and work well under pressure

  • Excellent written, oral communication, and presentation skills

  • Excellent leadership skills and ability to work with minimal supervision

  • Must be proficient in MS Office Suite products, including, Word, Excel, PowerPoint and Access

  • Ability to travel as necessary

  • Excellent negotiating skills and the capacity to relate well with cross-function teams and external networks outside of the company

Required/Preferred Education and Experience:

  • BS/BA degree in Engineering or Scientific discipline or equivalent experience

  • 7 - 10+ years Class II, Class III medical device regulatory experience

  • Experience with the interpretation and application of Quality System Regulations, ISO 13485, Canadian Medical Device Regulations, Medical Device Directive, and Medical Device Regulation

  • Regulatory Affairs Certification (RAC) by the Regulatory Affairs Certification Board (RACB) desired

  • Master’s degree in Regulatory or equivalent experience preferred

  • Class III PMA and Design Dossier regulatory experience preferred

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