Senior Regulatory Affairs Specialist APAC

Zoll Medical.; Selangor; On-site; MYR 60,000 - 85,000; Full time

Job summary

A leading medical technology firm is seeking a Regulatory Affairs Specialist in Malaysia to assist with regulatory compliance and product development. The ideal candidate will have a university degree, 3 to 5 years of experience in the healthcare medical devices industry, and knowledge of APAC and FDA regulations. Responsibilities include preparing technical documents, ensuring product compliance, and participating in internal audits. Join a dynamic team committed to improving patient outcomes.

Qualifications

• Working knowledge of APAC and FDA medical regulations.
• Experience with ISO 13485 standard is a plus.
• Ability to prepare technical dossiers for submissions.

Responsibilities

• Assist in implementation of regulatory compliance activities.
• Participate in product core teams for regulatory strategies.
• Monitor and maintain regulatory files and product licenses.

Skills

Proficient in Microsoft Office

Proficient in Adobe Acrobat DC

Positive work attitude

Ability to work under pressure

Organized and results-oriented

Education

University Degree

3 to 5 years of Regulatory Affairs experience

Job description

Acute Care Technology Job Summary

This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

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.

Essential Functions

• Understands and has working knowledge of APAC medical regulations,
• Understands and has working knowledge of FDA medical device regulations, European Medical Device Regulations, and/or other global regulations, ISO 13485 standard is a plus
• Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals
• Prepare technical dossier for submission to regulatory authorities in key target markets
• Prepare responses to agency's questions with good writing and communication skills
• Provide impact assessment to change orders for compliance with APAC regulations and standards
• Implement submission templates
• Monitors and maintains regulatory files in good order
• Monitors and maintains product licenses in good order
• Maintains current knowledge of device regulations, guidance and standards applicable to device product submissions. Analyzes the information and provides updates
• Participates in department improvement activities. Makes recommendations for process improvements to improve efficiency and accuracy of device submissions and other procedures.
• Assist with device recall activities
• Participate as an auditor in internal audit activities
• Report directly to Senior Manager, Regulatory Affairs Regional Leader, JAPAC

Skill Requirements

• Proficient in Microsoft Office, Adobe Acrobat DC
• Able to work independently and in a team, responsible and positive work attitude
• Organised, results-oriented and able to work under pressure

Required/Preferred Education and Experience

• University Degree with 3 to 5 years of Regulatory Affairs experience preferably in healthcare medical devices industry

Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

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.