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- Potential of becoming a regional role
- Diverse product lines
About Our Client
With a legacy spanning several decades, our esteemed client stands as a renowned multinational corporation, specializing in medical devices and healthcare solutions. As a leading player in the industry, their strong global presence and unwavering commitment to enhancing patients' lives are at the core of their mission. Pioneering innovation, conducting cutting-edge research, and delivering products of exceptional quality have earned them the trust of the medical community, making them a valued partner. Their extensive portfolio of products and services continues to push the boundaries of healthcare, making a significant impact on a global scale. Guided by their profound dedication to patient well-being and supported by a diverse and talented team, they fearlessly tackle some of the most critical challenges in healthcare today. Their relentless pursuit of growth and progress underscores their determination to shape a healthier, brighter future for all.
Job Description
- Lead and manage the QARA team, providing support, training, and mentoring to ensure the team's success.
- Align the regulatory and quality strategy with the overall business strategy across all functional areas.
- Facilitate communication within the QARA team and collaborate with other functions at the project level.
- Develop regulatory project plans in line with global, regional, and local marketing strategies.
- Oversee the delivery and launch of projects in the pipeline, accelerate approvals for key projects, and ensure timely delivery of GEOx project milestones.
- Maintain market access for existing products and manage product lifecycle activities.
- Foster relationships with regulatory authorities, acting as the main point of contact for critical issues on behalf of the company.
- Lead and support all registration activities for new products, plant registrations, license extensions, and variations, ensuring timely approvals.
- Monitor and ensure compliance with applicable regulatory requirements and internal quality standards.
- Participate in policy shaping activities by representing the company in industry associations.
- Support regulatory activities for specific product portfolios or projects.
- Review and approve labeling and standard operating procedures (SOPs).
- Review promotional material and SOPs for compliance with local regulations.
- Serve as a single point of contact for post-market product quality activities with the Taiwan Food and Drug Administration (TFDA).
- Enforce adherence to applicable GQPs/quality processes in the company.
- Achieve all local product quality-related KPIs (Key Performance Indicators).
- Collaborate with manufacturing plants to address significant quality issues and recommend process improvements to management.
- Establish communication with TFDA and Testing Centers for product quality management.
- Drive the local implementation of global FA (Field Action) plans in Taiwan.
- Develop and manage budgets for QARA activities.
- Display openness to potential role and geographic expansions as the company grows.
The Successful Applicant
- Strong knowledge of regulatory requirements and quality regulations in the medical device industry.
- Sound scientific background and understanding.
- Ability to manage complex projects and timelines in a matrix team environment.
- Excellent written and verbal communication and presentation skills.
- Demonstrated capability in managing multiple projects and meeting deadlines.
- Ability to identify compliance risks independently and escalate when necessary.
- Thorough knowledge of applicable procedures, specifications, regulations, and standards.
- Strong leadership and influencing skills to lead and motivate the team effectively.
- Capability to provide local and global stakeholders with interpretations of local regulations.
- Proficient in both written and spoken English.
What's on Offer
Join our innovative and dedicated team, where you will have the opportunity to make a significant impact on the success and growth of our medical device company. We offer a competitive salary, benefits package, and potential for future career expansion within our global organization.
