about the company.
Our client, a leading medical consultancy providing services including sourcing, market insights, marketing and sales, eCommerce, distribution and logistics as well as after-sales services is looking for a Senior Manager, Head of Regulatory Affairs to contribute to their business growth of Hong Kong.
about the team.
Lead a team of 2. Reports to the Commercial Director.
about the job.
- Manage the RA Departments to ensure resources and expertise are assigned to meet company goals, objectives and regulatory compliance; to ensure that regulatory strategies meet current and future customer needs; to provide ongoing coaching and feedback to develop the team
- Be a strategic partner and advisor to top management on all technical and legal matters related to Regulatory Affairs matters, to provide strategic planning and analysis to satisfy current and potential customer needs
- Ensure personal and team compliance, QMS procedures, policies and relevant medical device standards and regulations
- Provide expert opinions on technical and legal matters associated with the registration of products in the region to internal stakeholders
- Liaise and collaborate with various stakeholders in relation to all regulatory issues
- Facilitate communications between all stakeholders in order to get products registered in the region
skills & experiences required.
... - Bachelor Degree in life science related disciplines
- A certificate of registration and a valid Practicing Certificate issued by the Pharmacy and Poisons Board of Hong Kong
- 12+ years of solid RA experience, experience in Medical Device industry is preferred
- Solid experience with the global regulatory affairs principle, environments, experience in Asian & Europe markets is preferred
- Strategic planning and analysis
- Fluent in spoken and written English, good in Cantonese and Mandarin
Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https://www.randstad.com/jobs/q-hong-kong/ or contact Boris Lee at + 852 2232 3497 or email boris.lee@randstad.com.hk
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