ZOLL Medical

3 weeks ago

Senior Regulatory Affairs Specialist, APAC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Prepare and maintain regulatory submissions and supporting documentation to support the marketing of new or modified medical devices across domestic and international markets. Partner cross-functionally with QA, manufacturing, program management, product development, and marketing to ensure compliance and timely clearances. Communicate with US FDA, EU Notified Bodies, and EU Competent Authorities, manage FDA PMA/510(k) and CE files, and support labeling reviews, CAPA activities, audits, and required SOPs.

Location: Malaysia

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Support regulatory compliance by collaborating with QA, manufacturing, program management, product development, and marketing to ensure timely clearances and approvals.
•Represent regulatory affairs on project/product teams, risk management, and design review meetings.
•Develop and communicate global regulatory strategies and regulatory plans to cross-functional groups.
•Coordinate and maintain FDA PMA and 510(k) premarket notifications and prepare responses to regulatory agency letters.
•Coordinate and maintain CE files, manage Essential Requirement checklists, support labeling/promotional reviews, CAPA, regulatory audits/inspections, and write SOPs as needed.

Travel: Low travel

Key Requirements

•Bachelor's degree required.
•6+ years of regulatory experience in the medical device industry.
•Experience with medical device regulatory submissions, including 510(k) or PMA.
•Previous experience working with regulatory authorities for premarket and compliance activities.
•Knowledge of U.S. and European/international regulations and standards, including experience interacting with FDA and/or other regulatory agencies.

Experience:6+ yearsMedical devices

Education:Bachelor's

Skills:Project managementLeadershipCommunicationProblem-solvingAnalytical thinking

Company Brief

ZOLL Medical

Designs and manufactures medical devices and software for critical care and rescue, including defibrillators, ventilators, CPR feedback systems, and monitoring solutions for hospitals, emergency responders, and public access settings.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn

Loading job details...

Preparing the role view and application actions.

ZOLL Medical

3 weeks ago

Senior Regulatory Affairs Specialist, APAC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Location: Malaysia

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Support regulatory compliance by collaborating with QA, manufacturing, program management, product development, and marketing to ensure timely clearances and approvals.
•Represent regulatory affairs on project/product teams, risk management, and design review meetings.
•Develop and communicate global regulatory strategies and regulatory plans to cross-functional groups.
•Coordinate and maintain FDA PMA and 510(k) premarket notifications and prepare responses to regulatory agency letters.
•Coordinate and maintain CE files, manage Essential Requirement checklists, support labeling/promotional reviews, CAPA, regulatory audits/inspections, and write SOPs as needed.

Travel: Low travel

Key Requirements

•Bachelor's degree required.
•6+ years of regulatory experience in the medical device industry.
•Experience with medical device regulatory submissions, including 510(k) or PMA.
•Previous experience working with regulatory authorities for premarket and compliance activities.
•Knowledge of U.S. and European/international regulations and standards, including experience interacting with FDA and/or other regulatory agencies.

Experience:6+ yearsMedical devices

Education:Bachelor's

Skills:Project managementLeadershipCommunicationProblem-solvingAnalytical thinking

Company Brief

ZOLL Medical

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn