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

We are seeking a highly experienced Senior Specialist, Regulatory Affairs to join our team in Korea. This role is responsible for preparing regulatory submissions to support the marketing of new or modified medical devices in both domestic and international markets, as well as managing relevant post-market regulatory activities.

Essential Functions

Prepare and maintain regulatory submissions for domestic and international markets (e.g., 510(k), PMA, CE technical files).

Partner with cross-functional teams including Quality Assurance, Manufacturing, Program Management, Product Development, and Marketing to ensure regulatory compliance and timely product approvals.

Serve as the Regulatory Affairs representative on project/product teams, design reviews, and risk management activities.

Provide regulatory input and guidance on global regulatory strategies and standards.

Collaborate with department leadership to communicate with regulatory authorities (e.g., US FDA, EU Notified Bodies, Competent Authorities).

Coordinate responses to regulatory agency inquiries, deficiency letters, and audits.

Support the review of product labeling, promotional materials, and marketing content to ensure regulatory compliance.

Participate in CAPA processes and ensure timely closure of regulatory-related actions.

Stay current with changes in global regulations, standards, and guidance that may affect product compliance.

Write and maintain SOPs; train relevant personnel as needed.

Support and participate in regulatory inspections and audits.

Required/Preferred Education and Experience

Bachelor's Degree required. Regulatory Affairs Certification or a degree in Regulatory Affairs is a plus.

Minimum 6 years of regulatory experience in the medical device industry required.

Proven experience with regulatory submissions (e.g., 510(k), PMA).

Direct interaction with regulatory authorities related to pre-market and compliance activities is required.

Experience with international submissions and CE marking processes is strongly preferred.

Knowledge, Skills and Abilities

Strong knowledge of U.S., European, and international medical device regulations and standards.

Excellent verbal and written communication skills.

Strong project management and organizational skills.

Ability to prioritize multiple projects and meet deadlines with minimal supervision.

Analytical problem-solving abilities and a strong attention to detail.

Solid understanding of manufacturing processes, change control, and regulatory trends.

Familiarity with scientific terminology and engineering concepts.

Experience working with FDA and other global regulatory bodies.

Proficient in MS Office; experience with regulatory software tools is a plus.

Understanding of medical terminology is an advantage.

Travel Requirements

Up to 10% domestic and international travel may be 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.