生醫產業
先勁智能有限公司
資訊軟體、生物技術、研究發展服務業
工作內容：
1.Establishes, implements, and maintains the company’s Quality Management System to comply with applicable regulations and standards for medical devices.
2.Provides quality and regulatory affairs subject-matter expertise and advice to the business.
3.Collaborates with cross-functional teams to develop strategies, programs and processes to meet business objectives and ensure compliance with applicable standards and regulations.
4.Prepares pre-market regulatory submissions and communicates with regulatory authorities to obtain market authorization.
5.Investigates and resolves compliance matters, questions, or complaints and submits reports to regulatory authorities, as required.
6.Manages audit programs and conducts internal audits and supplier audits, as necessary.
7.Analyzes and communicates to senior management any significant proposed,new or changing regulatory requirements and standards impacting the business.
8.Leads regulatory authority and notified body audits and inspections on behalf of the company.
9.Educates, trains, advises, and coaches employees to ensure effective implementation of the QMS, and compliance with applicable standards and regulations.
Website: https://aheadmedicine.teamdoor.io/
需求條件：
1.Bachelor’s degree or equivalent experience in a relevant field
2.Strong Interests in Quality and Regulatory Affairs in the healthcare or life sciences industry. Medical device industry preferred.
3.Knowledge of Software as a Medical Device (SaMD) and agile development methods preferred.
4.Strong analytical and critical thinking skills
5.A keen eye for detail and a results-driven approach
6.Outstanding communication skills
7.Excellent organizational and leadership skills
工作地點：台北市
所需員額：1