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职责:
Job Summary
Provide dedicated support on a range of new medical device product registration activities which include develop regulatory and clinical strategies for new product registration, regulatory assessment and regulatory due diligence for China new opportunities, explore and assess regulatory pilot and green channels, draft CER(clinical evaluation report) and conduct product submissions, product change assessments, commercial supports, regulatory intelligence and regulatory compliance related activities, systems/process improvements and other responsibilities aligned with medical device regulation and business goals. Keep the good relationships with related registration agencies and government bodies.
Conduct regulatory and clinical assessment and regulatory due diligence for China new opportunities, explore and assess regulatory pilot and green channels- Develop and implement regulatory strategy and suitable yearly plan to ensure the key new product registration projects meet the set timeline
- Draft Clinical Evaluation Report to support new product registration as part of the registration document.
- Directly communicate with local authorities (Testing Lab, CMDE and NMPA) upon implementing regulatory strategies on submissions.
- Monitor regulation, policy and standard changes from government authorities that have impact to company’s products.
- Assess regulatory impacts on various product/process changes and support management review from regulatory compliance point of view.
- Review and approve advertising/promotional material to assure compliance with governing advertising/promotion as regulatory SME
- Perform other duties as needed
Qualifications
Education & Experience
- Bachelor’s Degree or above in related field
- 10-15 years’ experience in medical device regulatory affairs, previous experience in drafting CER and submission with clinical trial data is a plus
- Have hand-on experience in assessing and successfully implementing pilot policies in GBA/BoAo and/or Innovative Medical Device Green Channel approval is a plus
- Profound knowledge in cardiovascular industry is a plus
Skills
- Comprehensive knowledge of current regulations and guidelines
- Comprehensive knowledge in writing/drafting CER or comparison table and hand-on handling or clinical related question during registration assessment and registration review
- Fluent in English reading, writing and oral communications
- Familiar with MS Office applications
- Strong project management skills
Ability to adapt constant changes in fast pace
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