- Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
- Provide expert regulatory input to strategic decision making; including review, prioritization, and external communications
- Support the development and establishment of procedures, policies and standards
- Coordinate successful submissions and approval of applications
- Plan, undertake and oversee regulatory inspections
- Liaise and negotiate with regulatory authorities
- Provide advice about regulations to relevant stakeholder
- Review and report overall quality status
- Keep up to date with changes in regulatory legislation and guidelines
- Bachelor's degree in a science or related field
- 5+ years relevant experience within the Regulatory Affairs discipline
- Deep knowledge of the relevant Regulatory requirements for devices/products listed above
- Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
- Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
- Proven analytical skill and technical/scientific competence
- Attention to details and ability to appropriately assess risks
- Strong initiation and organizational skills
- Excellent communication skills, with ability to influence others and negotiate successful outcomes
- Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organisation
- Team-player, able to positively influence Team members at all levels
- Fluent in English
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Albemarle Shanghai, 中国 全职Description · Reporting to Manager of Communications and Public Affairs, China, the Communications Sr. Specialist will implement Albemarle's external communications strategy and support communication activities and campaigns to enhance Albemarle's brand in China. · D uties & Res ...
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AsstrA Shanghai, 中国 全职Foreign Trade Specialist · AsstrA is an ambitious team of 24 countries . More than 1,400 employees work in Europe, CIS countries, Asia and the USA. For more than 28 years, AsstrA has been offering a full range of transport and logistics services: road, sea, rail, air and int ...
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GR PMO
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Allnex Shanghai, 中国Position overview · allnex invites you to join our dynamic global regulatory affairs team in position of Regulatory Compliance Associate/Specialist in Shanghai, China. In this role, you will need to ensure, manage and control product regulatory compliance for allnex in China an ...
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Third Bridge Shanghai, 中国 全职Job Description · What is Private Equity (PE)? · In a nutshell, our private equity clients invest in companies with the intention of increasing the value of their stake down the line. The insights they get through our experts and content become the basis of their decision to in ...
Regulatory Affairs Specialist - Shanghai, 中国 - Sartorius
描述
Main Responsibilities & Tasks:
Qualifications & Skills:
