Senior Regulatory Affairs Specialist, APAC

6 days ago

Klang, Selangor, Malaysia ZOLL Medical Full time
Acute Care TechnologyJob 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.

Join our team. It's a great time to be a part of ZOLL

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

  • 3 to 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

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.

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