Regulatory Affairs Specialist

Regulatory Affairs Specialist (IVD/ 6-Month Contract)

 

6-Months Contract

Location: Jurong

Salary: Up to $6,000 depending on experience

Hybrid Work Mode (2 days WFH)

 

Our client, a global leader in specialty diagnostics, focused on advancing the diagnosis and management of blood cancers and immune-related disorders. The organisation is also highly regarded for its contributions to the global scientific and medical community.

 

Primary Function:

• To work as part of Asia Pacific regulatory affairs (RA) team for the in-vitro diagnostics product range for sale in Southeast Asia markets. 
• This role offers a chance to contribute to regulatory processes and compliance, ensuring product quality and safety.

 

Major Responsibilities:

• Compile and review technical documentation for product registrations in Southeast Asia countries.
• Review and edit dossier to meet countries’ requirements, ensuring accuracy and consistency of information.
• Provide documents to facilitate registrations in countries of responsibility.
• Support distributors in product registration, change notifications, and compliance with local regulations.
• Collaborate with internal and external stakeholders to overcome regulatory-related challenges.
• Response to questions related to product registration and change notification from regulatory agencies
• Keep track of license validity and ensure licenses are renewed in a timely manner.
• Manage Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
• Keep up to date with regulatory requirements and regulatory development in countries of responsibility
• Assist in Singapore SS620 GDPMDS audit.
• Provide input for regulatory change assessments to determine the impact on registrations

 

Requirements:

• B.Sc. in Life sciences or equivalent experience
• 2 - 5 years in regulatory affairs roles in healthcare industry (medical devices or diagnostics)
• Good knowledge of in-vitro diagnostics (IVD) regulatory requirements and willingness to continue learning and expanding regulatory expertise
• Familiar with product registration requirements in Southeast Asia countries
• Regulatory Affairs background with knowledge of Southeast Asia countries' IVD standards/ regulations

 

Lim Pey Chyi – [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423