Regulatory Affairs Specialist

JNPMEDI Inc.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading medical technology company in Singapore is seeking a Regulatory Affairs Specialist to manage product submissions and regulatory filings. The ideal candidate will have over 5 years of experience in regulatory affairs within the medical device sector, strong communication skills, and the ability to work across diverse teams. The role involves collaboration with international partners to ensure successful regulatory approval. Competitive salary and growth opportunities are offered.

Qualifications

• Minimum 5 years of regulatory affairs experience in a medical device company.
• Knowledge of regulatory requirements and processes for product approval.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Determine requirements for product submissions and regulatory filings.
• Provide regulatory guidance and review product design documentation.
• Collaborate with international teams for global regulatory submissions.

Skills

Regulatory affairs experience

Product lifecycle management

Risk management

Strong communication skills

Interpersonal skills

Job description

In 2020, JNP MEDI was founded with the aim of enhancing Korea’s globally recognized medical infrastructure by leveraging digital technologies such as blockchain and cloud computing through a cutting‑edge medical data platform.

We launched the clinical trial data management solution, Maven Clinical Cloud, which significantly contributed to the digital transformation of the clinical trial industry. In 2024, JNP MEDI expanded into professional services, integrating digital technologies into all aspects of our customers’ businesses beyond just clinical trial stages, marking another milestone in our growth.

Now, we are building networks with diverse clients and partners both domestically and internationally, progressing toward becoming a global enterprise.

Responsibilities

• Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
• Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes.
• Provide risk‑based guidance and regulatory input to projects and issues, ensuring cross‑functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.
• Participate in the development, review, and substantiation of product labeling and claims.

Requirements

• Minimum 5 years of regulatory affairs experience working in a medical device company.
• Regulatory knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirements.
• Ability to work in a fast‑paced environment and handle multiple projects simultaneously.
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism.
• Proactively seeks to develop and become well‑versed within the regulatory landscape.

Preferred Experience and Skills

• Experience authoring regulatory submissions for product approval.
• Previous experience working in a highly matrixed and geographically diverse business environment.

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