Regulatory Affairs Specialist

3 days ago

Singapore 4efa53ee-f627-46d5-b0b5-588ab5c91e20 Full time $60,000 - $80,000 per year

[About JNPMEDI]

In 2020, JNPMEDI 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, JNPMEDI expanded into professional services, integrating digital technologies into all aspects of our customers' business beyond just clinical trial stages, marking another milestone in its growth.

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

[Job Description]

  • In support of business priorities, 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 requirement
  • 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

[How to Apply]

Please submit your CV via email.

  • Email:
  • Email Subject: [Position Title] – Your Full Name

Kindly note that we only accept applications submitted through this email address.

Job Type: Contract

Contract length: 12 months

Work Location: Hybrid remote in Singapore 049422

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