Senior Regulatory Affairs Specialist, APAC

ZOLL Medical Corporation; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to support compliance in the healthcare sector. This role involves working with medical device regulations, preparing submissions, and ensuring that products meet all regulatory requirements. Join a dynamic team dedicated to improving patient outcomes through innovative medical technologies that save lives. The company values self-motivation and innovation, providing a meaningful career path for those passionate about making a difference in healthcare. If you thrive in a fast-paced environment and are eager to contribute to life-saving solutions, this opportunity is for you.

Qualifications

• 3 to 5 years of experience in Regulatory Affairs, preferably in healthcare.
• Strong understanding of APAC and FDA medical regulations.

Responsibilities

• Assist in implementing regulatory compliance activities.
• Prepare technical dossiers for regulatory submissions.
• Monitor and maintain regulatory files and product licenses.

Skills

Microsoft Office

Adobe Acrobat DC

Regulatory Affairs Knowledge

Communication Skills

Organizational Skills

Education

University Degree

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 the Regulatory Affairs department in implementing and administrating organizational 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.
• Prepares technical dossier for submission to regulatory authorities in key target markets.
• Prepares responses to agency's questions with good writing and communication skills.
• Provides impact assessments to change orders for compliance with APAC regulations and standards.
• Implements 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.
• Assists with device recall activities.
• Participates as an auditor in internal audit activities.
• Reports 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.
• Organized, 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 the 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' 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.