工作內容
Your Role
As Quality Assurance & Regulatory Affairs Manager, you will responsible for the development, implementation, and management of the company’s Quality Management System as well as its regulatory strategies and submissions. This role is accountable for regulatory and quality leadership across the business within a highly regulated medical devices environment. Your success in this position will help us to bring AI-based medical devices to market and empower physicians to more effectively provide patient care.
What You’ll Do
- Establishes, implements, and maintains the company’s Quality Management System to comply with applicable regulations and standards for medical devices.
- Provides quality and regulatory affairs subject-matter expertise and advice to the business.
- Collaborates with cross-functional teams to develop strategies, programs and processes to meet business objectives and ensure compliance with applicable standards and regulations.
- Prepares pre-market regulatory submissions and communicates with regulatory authorities to obtain market authorization.
- Investigates and resolves compliance matters, questions, or complaints and submits reports to regulatory authorities, as required.
- Manages audit program and conducts internal audits and supplier audits, as necessary.
- Analyzes and communicates to senior management any significant proposed,new or changing regulatory requirements and standards impacting the business.
- Leads regulatory authority and notified body audits and inspections on behalf of the company.
- Educates, trains, advises, and coaches employees to ensure effective implementation of the QMS, and compliance with applicable standards and regulations.
條件要求
- Bachelor’s degree or equivalent experience in a relevant field
- Minimum 5 years experience in Quality and Regulatory Affairs in the healthcare or life sciences industry.
- Proven experience with global medical device regulations and standards, including ISO13485, ISO14971, and US FDA requirements.
- Strong analytical and critical thinking skills
- A keen eye for detail and a results-driven approach
- Outstanding communication skills
- Excellent organizational and leadership skills
加分條件
- Knowledge of Software as a Medical Device (SaMD) and agile development methods preferred
- RA & QA experience in Medical device industry preferred.
薪資範圍
