Senior Regulatory Affairs Specialist, APAC

ZOLL Medical Singapore Pte Ltd; Kuala Lumpur; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading medical technology company in Kuala Lumpur is seeking a Senior Regulatory Affairs Specialist to ensure compliance across key global markets, focusing on the APAC region. Candidates must have a Bachelor's degree and at least 5 years of experience in regulatory affairs. The role involves developing regulatory strategies, preparing submissions, and maintaining regulatory files. The ideal candidate will be detail-oriented and possess strong communication skills.

Qualifications

• 5 years of regulatory affairs experience, preferably in healthcare or medical device industry.
• Maintain working knowledge of APAC medical regulations and ISO 13485.
• Participate in cross-functional product teams to ensure compliance.

Responsibilities

• Maintain regulatory files and product licenses in an organized manner.
• Prepare technical dossiers and regulatory submissions.
• Stay current with global medical device regulations.

Skills

Strong organizational skills

Time-management skills

Ability to work independently

Detail-oriented

Strong written communication skills

Strong verbal communication skills

Education

Bachelor’s degree in a relevant field

Job description

Senior Regulatory Affairs Specialist, APAC

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The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region.

Essential Functions:

• Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus
• Participate in cross‑functional product core teams to ensure compliance with internal policies and external regulatory requirements
• Develop, document, and implement regulatory strategy plans aligned with product development objectives
• Prepare technical dossiers and regulatory submissions for target markets
• Draft and submit responses to regulatory agencies with clear, concise, and well‑structured communication
• Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards
• Implement and maintain standardized submission templates and documentation
• Maintain regulatory files and product licenses in a well‑organized and up‑to‑date manner
• Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders
• Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy
• Support device recall activities as needed
• Participate in internal audit activities as an auditor

Required Education and Experience:

• Bachelor’s degree in a relevant field
• 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes:

• Strong organizational and time‑management skills
• Ability to work independently and collaboratively in a team environment
• Detail‑oriented, responsible, and proactive
• Able to perform under pressure and meet deadlines
• Strong written and verbal communication skills

To apply click – https://zoll.wd5.myworkdayjobs.com/ZOLLMedicalCorp/job/Selangor-Malaysia/Senior-Regulatory-Affairs-Specialist--APAC_R15695-1

About Us

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!

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Your application will include the following questions:

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ZOLL Medical Corporation, a leader in medical products and software solutions, helps responders manage, treat, and save lives in emergency rescues and in hospitals; outside the hospital while at work or home; in doctors' and dentists' offices and schools; in public places and on the battlefield. ZOLL's products contribute to managing patient care and saving lives, as well as increasing the efficiency of emergency medical, fire, and hospital operations around the globe.