Regulatory Affairs Coordinator

17 hours ago


Singapore EPIC MEDICAL PTE. LTD. Full time
Regulatory Affairs Internship

EPIC MEDICAL PTE. LTD. is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as a Regulatory Affairs Intern.

This exciting opportunity will provide the chance to gain hands-on experience in the preparation, submission, and monitoring of regulatory documents for healthcare/medical devices/pharmaceutical products.

As a Regulatory Affairs Intern, you will work closely with the Regulatory Affairs team to ensure compliance with local, regional, and international regulations.

Key Responsibilities:

  • Document Preparation: Assist in the preparation and submission of regulatory documents, including product registration, amendments, and renewals.
  • Compliance Review: Review and compile necessary documentation to ensure regulatory compliance for products.
  • Regulatory Research: Conduct regulatory research to stay up to date with current guidelines and requirements in target markets.
  • Database Maintenance: Help in maintaining regulatory databases and records.
  • Communication: Support the coordination and communication with regulatory bodies, health authorities, and notified bodies as required.
  • Product Compliance: Review product labeling and marketing materials to ensure compliance with applicable regulations.
  • Administrative Support: Assist in managing correspondence with internal stakeholders and cross-functional teams regarding regulatory activities.
  • Team Collaboration: Participate in department meetings and provide input as required.

Qualifications:

  • Education: Currently pursuing or recently completed a degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field.
  • Interest: Interest in regulatory affairs, healthcare regulations, or medical devices/pharmaceuticals.
  • Skills: Strong organizational skills and attention to detail. Good written and verbal communication skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office Suite.

We offer a dynamic and growing industry with hands-on experience in regulatory affairs. You will have the opportunity to gain exposure to regulatory processes and international standards. Our experienced regulatory professionals will provide mentorship and guidance throughout your internship.

Requirements:

  • Resume: Please submit your resume and a brief cover letter outlining your interest in regulatory affairs and relevant qualifications.


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