Regulatory Affairs Associate Manager

【Job Profile】

This role oversees the regulation process for products requiring Health Authority approval, including filing necessary applications and handling all Health Authority interactions.

【Job Responsibilities】

• Implement the regulatory strategies in the development and validation of ACTG molecular system products.
• Participate product development activities and provide support for regulatory processes and procedures including the development of project documents, product design protocols related to verification and validation, risk assessment, etc.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues and deliver to the product development teams.
• Acquire and maintain current knowledge of applicable regulatory updates and deliver (eg. announcements or training) to related teams.
• Coordinate the documents submission for regulatory submissions.
• Assist in submission activities for a variety of device regulatory approvals including US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, establishment registrations and listings, IVDR conformity assessment for CE marking, and Taiwan medical device registration, etc.
• Assess and document impact of proposed product changes on regulatory filings.
• Assist in the creation of Operating Procedures and policy guidelines.
• May perform other duties as required or assigned.

【Job Requirement】

• Master degree in life science or related areas.
• 2 years of working experience.
• Work in the pharmaceutical, biotechnology or medical device industry as regulatory affairs, regulatory compliance, quality engineer, quality assurance, or medical affairs role
• Good communication skills – ability to work on cross-functional teams
• Self-motivated by working independently and having the ability to take ownership of his/her responsibilities
• Previous experience in software development/ SaMD field is a plus
• Problem solving skills
• Previous experience in the development of IVD (molecular diagnostics) products is a plus
• Previous experience in regulatory affairs is a plus

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