RAQA Specialist, Singapore

About Applied Medical

As a new generation medical device company, we believe in the power of working together to make a meaningful and positive difference. Applied Medical is committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth.

We are dedicated to creating an environment where team members of diverse backgrounds are valued, challenged and acknowledged. Applied Medical’s products have been serving the Asian markets for over 20 years. To build sustainable partnerships in particular to our APAC markets, we are expanding our Regulatory Affairs and Quality Assurance (RAQA) team.

Overall responsibilities

The Regulatory Affairs & Quality Assurance (RAQA) Specialist is responsible for supporting and maintaining regulatory compliance and quality management system (QMS) activities across the APAC region. This role ensures medical devices are registered, distributed, and maintained in compliance with applicable regulatory requirements and quality standards, including ISO 13485 and country-specific regulations such as Good Distribution Practice of Medical Devices (GDPMD).

The position serves as a key liaison between regional commercial teams, global RAQA functions, distributors, and regulatory authorities to facilitate product registrations, post-market compliance, quality system effectiveness, and business continuity.

Position Description

• Essential duties
• Understand and follow Applied Medical's Quality Systems (QS) per training.
• Read, write, speak and communicate effectively with other team members, and comprehend work and safety instructions.
• Understand and comply with safety rules and Company policies.

Product Registrations

Obtain product registration approvals from relevant authorities in APAC according to organization's regulatory plan and strategy by compiling dossier as per local medical device regulations and collaborating closely with Headquarter Premarket team and authorities/distributors.

Change management

Perform regulatory assessments for product changes, labeling updates, design modifications etc.

Prepare, submit, and obtain approvals in a timely manner for changes initiated by Product Owner for continued market access.

Liaise with relevant stakeholders to ensure sufficient inventory is available for business continuity.

License renewals

Timely renewal of product registrations to ensure business continuity.

Post-Market Activities Process product complaints promptly

Adverse Event (AE) & Field Safety Corrective Action (FSCA) including recalls reporting to authorities in a timely manner.

Support in recall activities as required.

Local QMS (GDPMD)

• Participate in internal and external audits as required.
• Manage quality records and documentation in accordance with document control procedures.
• Support in the implementation and compliance of Quality Management System in APAC.
• Regulation changes
• Keep abreast with changes in the regulatory environment in APAC.
• Perform gap analysis to identify impacted areas due to changes in regulation and complete action items to address the impact.

Others

• Maintain regulatory databases, licenses, registrations, and regulatory records to ensure compliance.
• Perform additional duties and responsibilities as required by leadership.
• Attend on-site audit, as needed.

Team Member Working Relationships

Act as a liaison between RAQA and customers, regulatory agencies, suppliers, and internal teams.

Seek guidance and feedback from Manager, Headquarter RA team, and other leadership levels.

Position Requirements

Position qualifications

• Knowledge, skills, and abilities
• Ability to work independently and as part of a team.
• Analytical, meticulous and detail oriented.
• Assertive and not afraid to ask questions.
• Effective oral and written communication/presentation skills.
• Friendly, good attitude, customer service oriented.
• Ability to interpret existing and emerging regulations, standards, or guidance documents.

Education

Bachelor’s degree in engineering, physical or biological sciences, regulatory, other technical discipline, or equivalent preferred.

Training in Quality Systems including GDPMDS.

Experience

1-2 years of experience in Regulatory Affairs and/or Quality Assurance in the medical device industry.

Benefits

Applied Medical offers benefits package following local labor laws.