Circulation

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

Job Summary

Responsible for preparing regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.

Essential Functions

Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.Represent regulatory affairs on project/product teams, risk management, and all design review meetings.Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groupsWorking with department management provides global regulatory strategies and regulatory plansWorking with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authoritiesCoordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirementsCoordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certificationsCoordinates and prepares responses to FDA/NB or other such regulatory agency letters.Supports Reviews of product labeling changesReviews promotional literature and marketing materialsSupport CAPA and CAPA closureKeeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the companyParticipates in regulatory audits/inspections as requiredWrites SOPs and train key personnel as neededPerform other duties as assigned

Required/Preferred Education and Experience

Degree in Regulatory Affairs or Regulatory Affairs Certification preferredExperience with medical device regulatory submissions (510(k) or PMA preferredPrevious experience working with Regulatory Authorities relative to premarket and compliance activities preferredExperience with medical device submissions preferredRAPS certification is a plus Preferred

Knowledge, Skills and Abilities

Project management skillsMust be able to work under pressure to meet regulatory reporting time frames and company requirementsMust be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolutionKnowledge of U.S. and European/International regulations and standardsExperience interacting with FDA and/or other regulatory agenciesMust work well in team environmentsMust demonstrate leadership skills in team setting.Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scopeSolid understanding of manufacturing and change control, and an awareness of regulatory trendsUnderstanding of engineering concepts and scientific terminologySuperior interpersonal skillsExcellent communication skills, both oral and writtenProven ability to prioritize, conduct, and manage time to meet project deadlinesDocumented evidence of writing skillsBasic understanding of computer applications-Strong knowledge of Microsoft Office package, Windows and e-mail systems. Working knowledge of desktop computer and other software programsFamiliarity with medical terminology a plus

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Standing - OccasionallyWalking - OccasionallySitting - ConstantlyTalking - OccasionallyHearing - OccasionallyRepetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.