Regulatory Affairs / Clinical Support Specialist

Job Details

Location: Tai Seng

Employment Type: Full-time

Role Summary

We are seeking a detail-oriented Regulatory Affairs and Clinical Support Specialist to manage pre-market and post-market regulatory activities for Class I and II medical devices. This role bridges regulatory submissions for FDA and EU CE Mark with clinical evidence support to ensure market access continuity across global territories.

Key Responsibilities

Pre-Market & Lifecycle Activities

• Execute pre-market activities required to support the entire lifecycle of a medical device

• Involve in product design verification and validation activities according to regulatory requirements

• Establish technical files and 510k documentation to support CE marking and FDA clearance for Class I and II medical devices

• Perform risk analysis with appropriate risk mitigation measures

• Initiate clinical evaluation plans and reports based on clinical evidence and literature

Submissions & Approvals

• Prepare, compile, and submit regulatory registrations including product registrations, change notifications, and renewals to regulatory authorities in targeted countries

• Maintain existing approvals and ensure timely renewals to ensure market access continuity

• Collaborate with external regulatory consultants and partners to facilitate regulatory submission in targeted countries

Cross-Functional Support

• Provide regulatory guidance to cross-functional teams on regional regulatory requirements and strategies for new product development

• Draft and execute verification and validation test plans and reports in accordance with device requirements

Experience and Knowledge Required

• Minimum 3 years of experience in Life Sciences, Engineering, or a related scientific discipline

• Understanding of Class I and II medical device submissions for the EU and US, including MDD, MDR, and US FDA 510k

• Good organizational and communication skills

• Proficient in verbal and written English

Preferred Knowledge

• Understanding of regulatory framework for medical devices is preferred

• Knowledge of medical device standards: ISO 10993-1, ISO 8536-4, ISO 24971 is a plus

• Prior knowledge of ISO 9001 and FDA compliance

• Experience in drafting and executing verification and validation test plans and reports in accordance with device requirements

• Understanding of medical devices, specifically infusion pumps and closed system transfer devices, is good to have

Preferred Qualifications

• Familiarity with global regulatory submission processes

• Ability to work cross-functionally with R&D, Quality, and Clinical teams

• Experience managing product renewals and change notifications