Regulatory Affairs

Company Introduction

Cura & Konex Healthcare (also referred to as C&K Healthcare), operated by C&K Business Development Co., Ltd., is a full-service medical device distributor based in Thailand. We specialize in providing high-quality medical technologies and reliable services to hospitals and clinics nationwide.

The name Cura means care, representing our focus on improving patient outcomes. Konex stands for connection, reflecting our role in linking hospitals with advanced medical technologies. Together, the name captures our mission: delivering better care through strong healthcare partnerships.

With decades of experience, we offer end-to-end services, including product registration, importation, sales, marketing, and after-sales support through our in-house service engineering team.

Our Product Portfolio Covers:

• Respiratory Care

• Infusion & Injection Devices

• Surgical Equipment

• Endoscopic & Diagnostic Devices

• Patient Monitoring

• Vascular and DVT Prevention

• Advanced Wound Care

As a Thai enterprise, we are committed to advancing healthcare with a people-first approach and a clear mission: Empowering Healthcare, Enhancing Lives.

Job Summary

C&K Healthcare is seeking a Regulatory Affairs & Commercial Administration Specialist to support our fast-growing medical device business. This role combines regulatory affairs (RA) responsibilities with commercial administrative tasks, including tender opening review, preparation of tender documents, and sales ordering support.

The ideal candidate is detail-oriented, proactive, and able to balance regulatory compliance with business needs. This position is suitable for new graduates or candidates with 1–2 years of RA experience who are eager to grow in a dynamic, hands-on environment.

Key Responsibilities

1. Regulatory Affairs (Primary Scope)

• Prepare, analyze, compile, and edit technical documents required for Thai FDA regulatory submissions, including license registration, renewals, amendments, and post-market requirements.
• Coordinate with internal teams (e.g., Sales, Marketing, Service Engineering, Principals) to collect documentation needed for RA submissions.
• Maintain regulatory files and ensure timely renewals, device listings, and site registrations.
• Assist in preparing responses to Thai FDA queries within assigned timelines.
• Monitor updates to regulations, guidance documents, and standards relevant to medical devices in Thailand.
• Support complaint handling: assess complaint details, determine medical device reporting requirements, compile and submit reportable events, and support recalls or field actions when required.
• Support external regulatory audits and provide regulatory input to minimize compliance risks.
• Evaluate regulatory impact of product changes and participate as a reviewer in design or product modification projects.
• Support post-market surveillance activities, including documentation and follow-up.

2. Tendering & Commercial Administration (Secondary Scope)

• Support tender opening reviews and documentation checking during government procurement processes.
• Prepare tender documents, quotations, and coordinate required paperwork aligned with hospital procurement guidelines.
• Support sales ordering tasks, including administrative coordination, document preparation, and tracking of submissions.
• Assist the commercial team in organizing files, ensuring accuracy of documents related to tenders, quotations, and contracts.
• Liaise with hospitals and partners on administrative requirements related to tenders or documentation submissions.

3. Cross-functional Support

• Coordinate with internal departments (sales, marketing, service engineering, logistics) to support regulatory and commercial projects.
• Assist with other assigned tasks that contribute to regulatory compliance, commercial operations, or business needs.

Education Requirements

• Bachelor's degree in Science, or related technical/scientific field.
• A higher degree is an advantage.

Key Attributes & Skills

• Open to new graduates; 1–2 years of RA experience in the medical device or healthcare industry is preferred.
• Strong analytical skills and ability to interpret complex technical information.
• Excellent written and verbal communication skills (Thai & English).
• Detail-oriented, diligent, and able to manage multiple deadlines.
• Proactive, ethical, and results-oriented with strong project ownership.
• Skilled in MS Office and comfortable with digital systems/document portals.
• Ability to identify compliance risks and escalate appropriately.
• Demonstrates both creative and critical thinking in solving problems.

Travel Requirement

o   Standard workdays: Monday to Friday

o   Occasional field travel required for on-site troubleshooting and service support at customer locations

Compensation and Benefits

o   Competitive compensation package (base salary + monthly allowance), commensurate with experience

o   13th-month salary

o   Performance-based bonus

o   Social security contributions

o   Company-provided health insurance (inpatient and outpatient coverage)

o   Provident fund contribution