Manager of QRA China
We are looking for a proven leader who will foster growth and innovation as we achieve our goal of becoming the leading respiratory company in the world.
As the Manager of QRA China, you will report directly to the Vice President of Regulatory Affairs and have a hands-on role in defining, deploying, and leading organizational, process, and product quality requirements that directly impact multiple facilities and across the product life cycle.
In particular, you can expect to:
- Drive change and innovation by providing thought leadership and nurturing a culture of improvement and excellence.
- Lead, empower, and motivate highly effective RA & Compliance teams through mentorship and coaching – developing them professionally and to grow business.
- Serve as the Vyaire Management Representative in APAC per applicable regulations.
- Be responsible for timely country product registrations per local regulations with focus on time to market.
- Ensure effective implementation of Quality Systems and Compliance requirements per corporate policies and local regulations – continuously looking for ways to innovate process to drive business results.
- Work with government authorities regarding quality, regulatory and compliance issues.
- Monitor the activities of government regulatory authorities, globally, to ensure business is able to align with, comply with, and anticipate changes.
- Function as the SME for APAC country regulations and be responsible for the impact assessment for the new or revised regulations.
- Implement a Corporate Compliance program and manage post-market surveillance program per APAC local regulatory requirements – looking for opportunities to enhance the process.
- Develop productive relationship with internal partners to ensure compliance with regulatory requirements and provide support and thought leadership across the business.
- Prepare, present, defend, and manage the departmental budget and staff.
You will have the opportunity to:
- Improve patient outcomes
- Meaningfully impact the company’s short-term and long-term success
- Work closely with executives across the organization
- Grow your role as you see fit
- Learn about respiratory medical device manufacturing
- Create an inspiring and productive workplace
To be successful, you will need:
- 10 years of related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with at least 5 years of management experience.
- A dynamic change agent with the ability to analyze situations and implement solutions that drive strategy forward.
- Proven experience driving significant improvements with a team and business.
- Experience working in a global environment and leading multi-site enterprise level teams.
- Demonstrable experience building teams that create strategic change within the business.
- High energy, results-oriented leader with excellent collaboration and project management skills.
- Ability to make sound judgment in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements.
- Proven experience and knowledge in product submissions and PMS program per APAC regulations.
- Experience leading internal audit programs and managing external inspections/audits (e.g. FDA, Competent Authorities, and Notified Bodies).
- Effectively work with Corporate and platform QA and Regulatory Affairs partners.
- Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies.
- Bachelor of Science degree engineering or a scientific or technical discipline.
- Master of Science degree engineering or a scientific or technical discipline preferred.
- Six Sigma Black Belt or Master Black Belt strongly desired.
- Certified Quality Auditor and/or Manager or equivalent desired.
- Ability to speak multi-languages is desired.
- Based in Beijing, China.
- Travel required up to 30%, including international.
AP CHN Beijing - East Gate Plaza (CFN Emp@BD Site)