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- Prepare and submit product registration dossiers, design performance evaluation studies, and manage their execution with Clinical Research Organizations (CROs).
- Serve as an expert on medical devices laws and regulations for product registration in our target regions.
- Interface with regulatory agencies, track progress, and resolve issues raised during the review process.
- Contribute to product testing, clinical verification, data collection, and tracking efforts.
- Submit scientific special projects to regulatory agencies on behalf of the company.
- Establish strong relationships with key opinion leaders and regulatory bodies.
- Collaborate with cross-functional teams to achieve project goals and align with organizational objectives.
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Strong project management skills, including planning, execution, and timely communication. Excellent presentation skills.
- Proactive work attitude, strong communication and execution abilities, results-driven, and a team player.
- Meticulous and responsible individual who can handle stress and tight schedules effectively.
- Clinical Research experience.
- Knowledge of Clinical Research Organizations (CROs).
- Able to work well under pressure.
- Regulatory Affairs expertise.
- Critical thinking skills.
- Oncology and Biotechnology knowledge.
- Medical Devices understanding.
- Change Control and Presentation Skills.
- Familiarity with Regulatory Requirements.
- Life Sciences background.
Regulatory Affairs Executive - Singapore - ABIORES PTE. LTD.
2 weeks ago

Description
Job Description:We are seeking a highly skilled and experienced professional to fill the role of Regulatory Affairs Specialist.
Key Qualifications:
About You:
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General Affairs Service Executive
WENET SGP PRIVATE LIMITED- Singapore
-
Associate Affairs Executive
PropNex Realty Pte Ltd- Singapore
-
Regulatory Affairs Executive
This is an IT support group- Singapore
-
Regulatory Affairs Executive
Full time BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.- Singapore
-
Senior Regulatory Affairs Executive
EPM Scientific - Phaidon International- Singapore
-
Senior / Executive, Medical Affairs
IHH Healthcare- Singapore
-
Senior / Executive, Medical Affairs
IHH Healthcare- Singapore
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Executive Assistant, Medical Affairs
JOBSTUDIO PTE LTD- Singapore
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Executive Assistant, Medical Affairs
National Skin Centre Singapore- Singapore
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Safety and Regulatory Affairs Executive
Takasago International (Singapore) Pte Ltd- Singapore
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Executive Assistant, Medical Affairs
JOBSTUDIO PTE LTD- Singapore
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Executive Assistant, Medical Affairs
MCI Career Services Pte Ltd- Singapore
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Senior Executive, Medical and Scientific Affairs
Olympus APAC- Singapore
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Senior Assistant Executive/Executive, Accounts Receivable New Ministry of Home Affairs
National Library Board- Singapore
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Senior Vice President, Public Affairs, JAPAC
Page Executive- Singapore
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Events Executive RSIS
NTU (Nanyang Technology University- MainOffice-HR)- Singapore
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Senior Executive, AFA
NTU (Nanyang Technology University- Main Office-HR)- Singapore
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Senior Assistant Manager, Student Development
NTU (Nanyang Technology University- MainOffice-HR)- Singapore
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Student Care Teacher
WECRUIT PTE. LTD.- Singapore