Senior Regulatory Affairs Specialist, Apac

15 hours ago

Singapore Zoll Medical Corporation Full time

Resuscitation

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.

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

**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**:
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.

  • Regulatory Affairs Specialist

    1 week ago

    Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...

  • Surveillance Regulatory Affairs Officer

    2 weeks ago

    Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HERE!Be part of our diverse and...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore Poli Medical Company Pte Ltd Full time

    Company Description Poli Medical Company Pte Ltd, founded in 1971, began as a patent medicine manufacturer specializing in chinese pharmaceuticals and health supplements. Over the years, it has expanded to offer contract manufacturing/OEM services of private label health and food/health supplements and marketing/distribution of related products. Today, Poli...

  • Regional Regulatory Affairs Specialist

    2 weeks ago

    Singapore Reeracoen Singapore Pte Ltd Full time

    Job title: Regional Regulatory Affairs Specialist Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring...

  • Regulatory Affairs Specialist

    1 week ago

    Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Singapore Agilent Technologies Singapore Pte Ltd Full time

    **Responsibilities** As a Senior Regulatory Affairs Specialist, you will develop and implement programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with regulations, standards, company policies, and business objectives. You will perform activities that include: - Keeps abreast and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Reeracoen Singapore Pte Ltd Full time

    Overview Job title: Regulatory Affairs Specialist. Reference ID: 36639. Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and...

  • Specialist, Regulatory Affairs

    2 weeks ago

    Singapore ResMed (Malaysia) Sdn Bhd (MY) Full time

    About ResMed At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and...

  • Senior Regulatory Affairs Professional Apac

    1 week ago

    Singapore Johnson & Johnson Full time

    **Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Hong Kong, Hong Kong, Hsinchu City, Hsinchu County, Taiwan, Mumbai, India, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore Johnson & Johnson is currently seeking a...

  • Regulatory Affairs Executive, Apac

    1 week ago

    Singapore Symrise Full time

    **About Symrise AG** Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. Its sales of € 3.8 billion in the 2021 fiscal year make Symrise a leading global provider....