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 - [Confidential Information]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
