Annika Chen Email & Phone Number

Hong Kong

- Maintain consulting projects of mid to high complexity, with a focus on China inbound and outbound services.- Manage strategic consulting projects with key accounts to develop regulatory road-map for multiple product lines and oversee execution of device registrations;- Supervise and mentor Asia project management team;- Develop and maintain service.

Hong Kong SAR

- Maintain consulting projects of mid to high complexity, with a focus on China, Brazil, Mexico and the US market;- Develop and maintain service tools as service lead for China market;- Develop and provide training for new project managers and consultants;- Provide Hong Kong LRP support.

Hong Kong SAR

- Manage global consulting projects, with a focus on Asia markets;- Develop service tools and provide business development support for China market, conduct internal training on China regulation;- Provide Hong Kong LRP support.

Beijing City, China

- Develop regulatory strategy of medical device launch according to company's business strategy;- Prepare and submit regulatory premarket submissions for China National Medical Products Administration (NMPA) for multiple product lines;- Maintain post-market regulatory compliance.

Beijing City, China

- Manage mid-high complexity medical device regulatory consulting projects;- Liaise with partner company and ensure project processes are aligned;- Maintain record of operational activities;- Provide communication support for consultants and management team.

Beijing, China

- Prepare and submit regulatory premarket submissions for China National Medical Products Administration (NMPA) for multiple medical device products;- Liaise with NMPA and clients to make sure questions regarding premarket submissions are addressed in a timely manner;- Ensure regulatory requirement are accurately conveyed to clients.