1. Location/Division Specific Information
Taiwan/ Specialty Diagnostics Group
2. What will you do
We collaborate with the sales team to make sure the efficient regulatory strategy meet the required legislation in Taiwan for the local market access.
We assess current / emerging regulations and corporate / industry standards for impact on the business area, collaborate optimally with the commercial team in Taiwan, product portfolio expansion for the company.
3. How will you get here
Education:
We need Bachelor's degree or above in Life Science/ Biochemistry/ Medical technology or any Science related fields.
Experience:
Project management experience to efficiently handle regulatory submission projects with at least 3 years of meaningful work experience in Regulatory Affairs/ Quality Assurance.
Knowledge/ Skills and Qualification:
We need one with knowledge of in vitro diagnostic and/ or medical device registration and submission process in Taiwan. Understanding of GDP regulations or ISO 13485 is advantage
We need someone who is a good teammate, that can work with the team members across the different countries. Positive demeanor is important and be proactive and pragmatic.
We need a person with clear and confident spoken communication skill as well as good listening skills. A good command of written and verbal communication skills in English is preferred.
4. Key Responsibilities:
Drives regulatory and quality processes of the company.
Conducts product registration/ QSD certification and support the business with the expansion of the product portfolio and new product introduction in alignment with the organization’s strategies.
Collaborates with manufacturing sites from each Business Unit (BU) on the registration projects and proposes the measurable inputs as to achieve the earliest possible approvals of go-to-market.
Review of dossier files before submission and collaborates with BU’s regulatory team to resolve technical and documentation gaps.
Maintains the registration data and reviews BU labeling in compliance with Taiwan TFDA requirements.
Coordinates and provides assessment on product change to ensure the regulatory change will not impact the product compliance in the market.
Maintains and compiles Quality Management System results and provides to applicable partner internal and external.
Supports audit and inspection preparation, resolution of the findings and liaises with auditing groups and inspectors through all stages of the audits.
Works directly with partners to provide process analyses oversight on a continuing basis to ensure requirements and regulations are met.
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