Regulatory Affairs Executive (RA)

Job Overview:
We are seeking a Regulatory Affairs Executive to support product registration and ensure compliance with medical device regulations in various jurisdictions. The ideal candidate is detail-oriented, organized, and familiar with regulatory documentation and submissions.

Key Responsibilities:

• Assist in maintaining regulatory approvals and product registrations in line with local and international requirements.
• Prepare and submit documentation for product registration, license renewals, and endorsements.
• Monitor updates in regulatory guidelines and ensure documentation is updated accordingly.
• Maintain accurate regulatory records and registration master lists.
• Coordinate with regulatory authorities and commercial partners on documentation and endorsements.
• Support product vigilance activities including advisory notices, safety actions, and incident reporting.
• Distribute and follow up on customer feedback questionnaires; analyse feedback and prepare reports.
• Support internal, supplier, and external audits related to regulatory compliance.
• Participate in risk management and other cross-functional initiatives as needed.

Requirements:

• Diploma or Degree in related field
• Basic knowledge of medical device regulatory requirements (e.g., MDA, EU MDR, etc.)
• Strong attention to detail and good documentation skills
• Good communication and coordination abilities
• Ability to work independently and in a team

Contact Name: Arthur Lee

Email Address: arthur@peoplelake.asia

Contact Number: 60125805506