Work Flexibility: Hybrid

About the job:

Responsibility for ensuring on premarket submission and registration in compliance manner.Compilation of submission dossiers working with design divisions, monitoring and do completion for new product, line extension, amendment, update, related certification.Communication strategy of local submission and registration with design divisions and commercial.Review, track and manage Change Notification coming from divisions and do the required action.

What you will be doing:

The following include but not limited to:

Prioritize, plan, and review product registrations for respective product lines.Prepare, coordinate and submit regulatory applications to the local health authority.Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.Provide the management team with regular updates on product registration & regulatory trends.Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.License data management on internal system and external platform.Participate in the post registration activities like local labeling, UDI, registration data management, etc.

Who are we looking for:

Degree holder, healthcare/medical/engineering related major is preferred but not limited to.Relevant regulatory experiences in international company for 3 years.Ability to interact, influence and partner with leaders.Detailed oriented.Excellent communication skills with proficiency in spoken and written English and Chinese.High ethical standards and integrity.Well-organized and logical thinking.Project management, writing, coordination, and execution of  regulatory items.Perform technical and scientific regulatory activities.Good at planning and business processes, patient and a great sense of responsibility.Project management, writing, coordination, and execution of  regulatory items.Seeks out diverse ideas, opinion, and insights and applies them in the workplace.Connects and relates well with people who think and act differently than oneself.Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources.Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.

Travel Percentage: 0%