Ctry Approval Specialist
Are you passionate about ensuring compliance and approval for products entering different countries? Are you detail-oriented, with a strong understanding of global regulations and requirements? Thermo Fisher Scientific is seeking a Country Approval Specialist to join our team and make a difference in the global healthcare industry. In this role, you will play a crucial role in obtaining necessary approvals for our products to enter new markets and help us expand our reach. If you are a self-motivated individual with excellent communication skills and a desire to make a positive impact, we invite you to apply for this exciting opportunity.
- Conduct thorough research and stay up-to-date on all global regulations and requirements for product entry into different countries.
- Collaborate with cross-functional teams to obtain necessary product information and documentation for submission to regulatory bodies.
- Utilize strong attention to detail to ensure all required documents are complete and accurate before submission.
- Communicate effectively with regulatory agencies and other stakeholders to obtain necessary approvals and address any concerns or inquiries.
- Develop and maintain a thorough understanding of the company's products and their intended use in order to accurately represent them to regulatory agencies.
- Identify potential roadblocks or delays in the approval process and proactively work to resolve them.
- Maintain organized records and documentation of all submissions and approvals.
- Monitor and track changes in regulations and requirements to ensure ongoing compliance for existing and future products.
- Participate in internal and external audits to ensure compliance with regulations and company standards.
- Continuously seek opportunities to improve processes and procedures related to product approvals and compliance.
Excellent Communication And Interpersonal Skills, With The Ability To Work Collaboratively With Cross-Functional Teams And External Stakeholders.
Bachelor's Degree In A Relevant Field Such As International Business, Regulatory Affairs, Or Life Sciences.
Minimum Of 3-5 Years Of Experience In Country Approval Processes For Medical Devices Or Pharmaceutical Products.
In-Depth Knowledge Of Global Regulatory Requirements And Submission Processes For Various Regions, Including But Not Limited To Europe, Asia, And Latin America.
Strong Attention To Detail And Ability To Manage Multiple Projects Simultaneously.
Quality Assurance
Data Analysis
Time Management
Attention to detail
Project coordination
Regulatory compliance
Problem-Solving
Documentation management
Cross-Functional Collaboration
International Standards
Country Regulations
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Multitasking
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Ctry Approval Specialist in Beijing, China is between ¥196,000 and ¥350,000 per year (approximately $28,000 to $50,000 in USD). This salary range can vary depending on factors such as the specific industry, company size, and individual qualifications and experience.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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