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The Position
Roche Diagnostics
Job Summary :
Ensure locally launched MD/IVD products under the name of RDTW are complied with relevant regulations, including but not limited to product registrations and review of promotional materials. RDTWMD/IVD,
Engage and maintain the good and close relationship with TFDA and other internal & external key stakeholders. TFDA
Monitor and analyze key regulatory policy trends and translate into predictive insights to support management of product launch and during product lifecycle. Assist line manager to handle tasks and projects as necessary. ,
Main Tasks & Responsibilities :
Act as the regulatory point of contact for global/regional product launch projects in planning and managing local submission projects with the alignment on local launch plan.
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Make concrete registration plan for new and conversion products and provide strategic advices to management;
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Ensure that company's products comply with Taiwan FDA issued regulations and registration requirements, including but not limited to:
- New product approvals: planning, submission and liaising with regulatory authorities for marketing authorization;
- Product changes, license variations and renewals: monitoring and planning of required submissions, ensure timely approvals as required by local regulations and timeline of company implementations;
- Specifying labelling and packaging requirements;
- Perform promotional materials review, review and/or approve materials which descriptions and statements of a specific product are aligned with locally approved claims
FDA,:
Others :
- Proactively deal with daily works that might have law/regulatory concerns and properly maintain corresponding documents/records as required./,/
- Other projects or tasks assigned by line manager.
- Conduct business in full compliance to Behavior in Business and Behavior in Competition ,
Power Reserved
Observance and adherence to regulations and other contents stated in the prevailing Standard Operating Procedures and Delegation of Authority Manual
Basic Requirements of the Job :
Education :
Bachelor degree or above, subject in medical laboratory/engineering, pharmaceuticals or Science related fields.
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/ Experience, Skills & Qualifications:
- 2-3 years of experience in Regulatory Affairs in a IVD/Medical Devices company/fields IVD// 2-3
- Native Mandarin and fluent English in listening, speaking and written ,
- Ability to manage multiple projects and deadlines
- Written and verbal communication skills
- High level of commitment and initiative
- Possess the leadership to lead cross-functional teamwork, engage, and motivate the team to bring the greatest impact ,
- Fast learner in all aspects and thrive in a fast-paced environment ,
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
