Regulatory Affairs Specialist (Contract/Up to $5500) - #1106883

Job Description & Requirements

Reporting to the Regulatory Affairs & Compliance (RAC) leader, you will be responsible for Regulatory Affairs and Syndication activities for Health Care Business (HCB). Successful candidate is expected to support business growth, market continuity, and mitigate the compliance risk for Singapore and Malaysia.

Responsibilities:

• Assist with pre-market regulatory clearances and post-market regulatory activities.

• Support regulatory assessment and determine registration plan with business division for strategic implementation.

• Assist with assigned rebranding activities for SEA team.

• Familiarize with registration requirement.

• Collect and assess registration dossier and address the gap of technical deficiencies.

• Submit registration dossier and follow through all in-process evaluation until regulatory clearance is obtained.

• Act as the liaison for HCB commercial support.

• Assist with all regulatory administrative support for division and commercial

• Manage regulatory system and tool to drive operational excellence for effective data tracking and ensure regulatory data integrity.

• Execute all warranted FSCA and follow-up all through until closure, including preparation and submission of relevant FSCA reports to regulatory authority.

• Assist with adverse event report and follow-up through until closure to ensure regulatory compliance.

• Review and approve promotional materials to ensure all business claims in the range of registered scope.

• Participate in projects to manage data needs for emerging global regulations.

• Publish data to partner software and prepares data for syndication.

• Work closely with Global RAQ Data & Syndication team to support Area process development and global process standardization.

• Data Management execution of related Regulatory Affairs data to support Area needs.

• Support any other duties within the role or task assigned from time to time

Qualifications:

• Bachelor of Science or Biomedical Science related

• Relevant Experiences in health care industry required

• Around 2 years of regulatory working experiences, preferably in medical device industry

• Knowledge of ASEAN medical devices regulatory requirement

• Self-learner and comfortable with continuous learning in regulatory and technology subjects

Interested candidates may apply through the application system.  Shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao

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