JOB DESCRIPTION:

Main Responsibilities:*

Product Related Registrations/Submissions

Prepares product registration application for government filings of all types. This includes preparation of submission packages and input responses. Managing approval timeline within business unit’s expectation and original planned.

Relationships

Provides regulatory, compliance advice, consultation and support to other functions. Built and maintained positive relationships internally and externally including regulatory agencies, trade organizations. Externally, it is required to build strong relationship with Taiwan FDA to mitigate registration risk and meet RA goals. Internally, provide business unit insight on competitor approval status periodically.

Compliance Across Life Cycle

Manages products, programs and change control in compliance with applicable global and local regulations. Maintain an awareness of local regulatory requirements that impact the company regarding development and maintenance of products throughout the product life cycle. Maintains awareness of legislation and current developments within responsible business areas.

Regulatory Strategy

Assists to develop and maintain regulatory strategic documents. Identifies regulatory risks/opportunities for projects in area of responsibility and proposes strategies. Elevates significant risks through reporting line with options for resolution.

Regulatory Process Improvement

With oversight, develops, maintains and suggests improvements to procedures, work aids, IT, etc. to manage existing and/or quickly transition products into / out of our scope of responsibility. Identifies opportunities for efficiencies, business process improvements and cost reductions related to regulatory affairs.

Others

Completes training as required and assigned before performing tasks. Performs tasks in compliance with relevant requirements and according to established policies and procedures, and requests clarification when concepts or requirements are unclear. Administrative tasks included and also other tasks as assigned by manager.

Skills & Experience Required:*

Skills:

Organized and attention to detail

Good interpersonal and communication skills

Good command of written and spoken English

Adaptable to complex environment and tasks

Accountable for owns actions and can work independently

Experience:

• At least 3 years of regulatory affairs experience in medical device related fields with multinational companies as preferred
• Familiar with Taiwan FDA submissions and processes
• Bachelor's Degree or above in pharmacy, biology, chemistry, pharmacology, or related field is preferred.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

Taiwan > Taipei : No. 407, Ruiguang Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable