Main Responsibilities:*

• Responsible for managing all regulatory, and quality affairs activities within Taiwan for ADC.

• Act as Taiwan RA lead in registration and provide registration strategy for ADC products.

• Manage the routine Quality Assurance operations within the Affiliate for ADC and responsible for development, training, implementation and monitoring of quality systems for ADC Taiwan.

Skills & Experience Required:*

• BS degree in medical device/engineering or related fields.

EXPERIENCE /QUALIFICATION

• Minimum 5-year experience in regulatory affairs and quality assurance in medical device, pharmaceutical or related industry.

• Previous experience should demonstrate the ability to prepare product registration documentation in Taiwan

• Familiarity with the Taiwan Medical Device Laws and related regulations and regulations such as ISO 9000/13485, QSR

• Effective communication and coordination skills

• Proven project management skills

• Good command of written & spoken English and computer software skills

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com