Compliance Officer

ABOUT PERCEPTRA

Perceptra is Thailand's pioneering deep health tech innovator, revolutionizing healthcare through cutting-edge AI solutions. We build intelligent solutions that tackle critical challenges in the medical field with measurable impact. Our flagship products—Inspectra CXR and Inspectra MMG—stand as Southeast Asia's premier AI-powered medical imaging analysis platforms, featuring eight sophisticated deep learning services deployed via cloud infrastructure. We seamlessly integrate with hospital IT systems through our intuitive web interface and robust API services, enhancing radiologists' diagnostic capabilities and workflow efficiency. With over 100 hospitals nationwide already relying on our technology, we're expanding rapidly and seeking exceptional talent to join us in transforming healthcare across the region.

ABOUT THE POSITION

As an entry-level Compliance Analyst at Perceptra, you will provide essential tactical support to our compliance department. This role is foundational to our mission, focusing on the day-to-day tasks that ensure our AI-powered medical imaging solutions, Inspectra CXR and Inspectra MMG, adhere to all relevant healthcare laws and regulations.

ROLES AND RESPONSIBILITIES

Regulatory Monitoring & Surveillance

• Monitor relevant regulations and standards across key markets (Thai FDA, US FDA, HSA, ISO 13485, IEC 62304, PDPA/ISO 27001) and prepare periodic intelligence summaries on regulatory changes that may impact Perceptra's AI products

• Track and maintain accurate records of regulatory submissions, product registrations, licensing files, and correspondence with regulatory authorities across jurisdictions

• Assist in preparing detailed reports on compliance activities for review by senior staff and management.

• Support the processing and documentation of product feedback and nonconformance reports for our AI software.

Compliance Operations

• Support product registration and market authorization processes for new products and markets, coordinating with internal teams and external consultants as needed

• Process and document product feedback, complaints, and nonconformance reports in line with the company's ISO 13485 QMS

• Assist coordinate internal and external audits by gathering necessary documentation related to our ISO 13485 Quality Management System (QMS).

• Assist in the preparation and timely submission of periodic regulatory reports, and liaise with internal stakeholders to complete surveys and questionnaires requested by regulators

• Conduct compliance induction sessions for new staff and coordinate mandatory training completion across the organization, maintaining up-to-date training records and declarations

• Work with internal teams and external parties on compliance-related matters and reporting requirements

QUALIFICATIONS:

• Bachelor’s degree or equivalent.

• High problem-solving, communication, attention to detail and interpersonal skills

• Ability to operate independently and to multi-task

• Good in Office Software (MS/Google Excel, PowerPoint, Word Google Sheet, Slides, Docs and process flow chart etc.)

• Reasonable understanding of Compliance role and risk-based Compliance approach, and ability to identify and remediate key Compliance risks

• Proficient in reading and writing skills inThai and  English

• 1-3 years’ of Compliance/audit/regulatory experience in the medical or healthcare sector are preferred.

The opportunity is also open to fresh graduates who are bright and eager, and interested in a potential career in Compliance.

Please submit your resume and a cover letter outlining your relevant experience and interest in the position.

BENEFITS AND PERKS

• Monthly salary based on experiences + performance-based bonus
• Welfare : life & health insurance package.
• Perks : Laptop, annual company retreat.
• Office close to BTS Thonburi.
• Work from home 1-3 days per week.