Regulatory Affairs Specialist (Medical Devices)

Job Main Purpose:

In country Regulatory Affairs to support Bayer Radiology Vietnam business, focused on medical devices.

YOUR ROLE & RESPONSIBILITIES:

• With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for Vietnam registrations for Bayer Radiology medical devices.

• Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.

• Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for Vietnam as per required timelines to the Global Regulatory Affairs teams.

• Review the labelling materials to ensure the compliance to local labelling requirements. Drive global, regional and local stakeholders for the labelling compliance to Vietnam regulatory requirements.

• Monitor and communicate the new or updated regulations from Vietnam, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of Vietnam are kept up to date in database systems.

• Develop and maintain tracking of regulatory activities, including submission prioritization, submission status tracking and submission dossier archiving.

• Support Regulatory device internal processes/SOP/KPI development and roll-out related to Vietnam regulatory activities.

• Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advice from Vietnam regulatory standpoint.

• Work in close collaboration, ensuring prioritization, alignment and effective communication with APAC Device Regulatory Head, Vietnam RAD Commercial and Global Regulatory Affairs teams.

• Perform other appropriate duties as assigned by management to support the regional/local radiology business.

• MS or BS degree in Engineering, Pharmaceutical, Chemistry or Biological Sciences.

• At least 3 years of proven Vietnam regulatory experience in pharmaceutical or medical device industry, including hands on Vietnam registration experience and direct working experience with IMDA and other regulatory authorities as required for medical devices.

• Familiar with local regulations and regulatory assessment of device design.

• Ability to multitask and focus on multiple issues at one time, prioritize direct diverse activities in a changing environment often under time pressure in a highly regulated environment.

• Proven ability to communicate effectively in English both verbally and in writing.

• Skill and determination to reach successful outcomes in negotiations with both internal cross-functional and external parties.

• Detail oriented and well-organized.

• Excellent interpersonal skills, motivated to work independently as well as with cross-functional teams in line with our company LIFE values and to effectively support RAD businesses.