Regulatory Affairs Specialist
This role involves managing technical documentation for product registrations and changes in the APAC region at Thermo Fisher Scientific. The specialist will collaborate with cross-functional teams to ensure compliance and handle adverse event reporting. Candidates must have experience in IVD or medical device regulatory affairs and knowledge of APAC regulations. The role requires a strong background in QMS and excellent organizational skills.
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Experience
3-5 years
Function
Research
Work mode
Onsite, Singapore
Company
Tier 1
What you will work on
This role involves managing technical documentation for product registrations and changes in the APAC region at Thermo Fisher Scientific. The specialist will collaborate with cross-functional teams to ensure compliance and handle adverse event reporting. Candidates must have experience in IVD or medical device regulatory affairs and knowledge of APAC regulations. The role requires a strong background in QMS and excellent organizational skills.
TAL's take
Strong tier-1 company with a clearly defined role in the medical device regulatory space.
The JD clearly outlines the specific APAC-focused regulatory responsibilities, product scope, and required experience.
Salaries at Thermo Fisher Scientific
17.4 LPA average
Based on 13 Grapevine salary entries for Thermo Fisher Scientific.
Finance
0 - 2 years | Contractor
3 LPA average
Range: 3 - 3 LPA
Other roles
0 - 2 years | Contractor
9 LPA average
Range: 9 - 9 LPA
Other roles
2 - 4 years | L5
13 LPA average
Range: 13 - 13 LPA
Other roles
4 - 6 years | L5
12 LPA average
Range: 12 - 12 LPA
Must haves
- 3-5 years in Regulatory Affairs roles
- Experience in IVD or medical devices industry
- Proven success in product registrations in Asia Pacific
- Knowledge of APAC IVD standards and regulations
- Understanding of quality management systems
- B.Sc. in Life Sciences
Tools and skills
About the company
Thermo Fisher Scientific is a global leader in life sciences and diagnostics.
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