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.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose.
Join our team. It’s a great time to be a part of ZOLL!
Job Summary
The Senior Specialist, Regulatory Affairs is responsible for preparation of 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 groups
- Working with department management provides global regulatory strategies and regulatory plans
- Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
- Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
- Coordinates/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 certifications
- Coordinates and prepares responses to FDA/NB or other such regulatory agency letters.
- Supports Reviews of product labeling changes
- Reviews promotional literature and marketing materials
- Support CAPA and CAPA closure
- Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
- Participates in regulatory audits/inspections as required
- Writes SOPs and train key personnel as needed
Required/Preferred Education and Experience
- Bachelor's Degree required
- 6+ years of regulatory experience in the Medical Device Industry required and
- Experience with medical device regulatory submissions (510(k) or PMA) required and
- Previous experience working with Regulatory Authorities relative to premarket and compliance activities. required and
- Experience with medical device submissions required
Knowledge, Skills and Abilities
- Project management skills
- Degree in RA or Regulatory Affairs Certification a plus
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements
- Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
- Knowledge of U.S. and European/International regulations and standards
- Experience interacting with FDA and/or other regulatory agencies
- Must work well in team environments
- Must demonstrate leadership skills in team setting.
- Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Understanding of engineering concepts and scientific terminology
- Superior interpersonal skills
- Excellent communication skills, both oral and written
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Documented evidence of writing skills
- Basic understanding of computer applications
- Familiarity with medical terminology a plus
Travel Requirements
- 10% travel required
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' 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.
Skills Required
- Bachelor's Degree
- 6+ years regulatory experience in the medical device industry
- Experience preparing medical device regulatory submissions (510(k) or PMA)
- Experience working with regulatory authorities (FDA, Notified Bodies, Competent Authorities)
- Experience preparing and maintaining CE files and Essential Requirements checklists
- Knowledge of U.S., European and international medical device regulations and standards
- Project management skills
- Ability to support CAPA activities and closures
- Proven written and verbal communication and documentation skills (SOP writing, training)
- Degree in Regulatory Affairs or Regulatory Affairs Certification
- Familiarity with medical terminology
ZOLL Medical Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ZOLL Medical Corporation and has not been reviewed or approved by ZOLL Medical Corporation.
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Healthcare Strength — Medical, dental, and vision coverage includes in‑network preventive care at 100% along with behavioral health/EAP and virtual therapy options. These features are often regarded as solid to good components of the package.
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Parental & Family Support — Paid parental leave provides 12 weeks at full pay for the birthing parent and 6 weeks for the non‑birthing parent after eligibility is met. This policy is frequently highlighted as a standout element.
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Wellbeing & Lifestyle Benefits — Wellness programs offer incentives and are complemented by multiple external well‑being recognitions. These programs add perceived value to total rewards.
ZOLL Medical Corporation Insights
What We Do
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries.
