Senior Director of Quality Assurance and Regulatory Affairs, China
Job ID :
China - Shanghai
- Develop and implement China CFDA Registration (including Clinical Affairs) and CFDA compliance strategies for new and current products, taking into account current and proposed changes in CFDA regulations, clinical partners, CFDA audit practices, technical methods and standards.
- Ensure post-market product CFDA compliance, demonstrated by timely, consistent review of recall notification within statutory guidelines, minimizing the risk of CFDA actions that could impact our business.
- Establish and maintain close relationships with appropriate China regulatory agencies for effective registration requirements and post-market activities
- Maintain strong working relationship with China Commercial organizations to ensure alignment of regulatory strategies to business priorities.
- Develop company capability to manage closed-loop quality processes in China. This includes development of processes and talent.
- Communicate with regulatory agencies to determine status and facilitate approvals of products registrations
- Remain abreast of changes in relevant regulations including product testing, clinical trial, product registration and post-marketing action both proposed and implemented. Effectively communicate this information to the appropriate functional groups
- Provide guidance for the effective clinical studies and facilitate the product registrations within the budget and expected timeline
- Supply regulatory impact of proposed changes to current manufacturing processes and marketing strategies
- Maintain expert knowledge in product specific China regulatory requirements and be a point of contact/consult for registration strategies
- Maintain strong working relationship and communications with Business Group regulatory leaders.
- Construct a strategic vision for development of the organization and the people. Passionately develop skill and capability
- Represent Company in various agency and industrial conferences in China
- Build and develop a high performing regulatory affairs team.
- Prevent business interruptions due to compliance issues
- Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
- Ten years of supervisory and management experience
- Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics
- Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics.
- Experience in registration and commercialization of medical device and diagnostic products.
- Ability to develop effective regulatory strategies and apply regulations to pre-market and post-market strategies.
- Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Product Development.
- An established personal relationship with the CFDA and other regulatory agencies.
- Proven leadership and managerial skills in order to build and sustain a vision for the work group.
- Demonstrated track record of developing organizational capability.
On-Target Personal Skills and Attributes
- Collaborative leader, building consensus while championing global regulatory initiatives.
- Solution focused and always with decisions and actions grounded in data and facts.
- Ability to adapt to complex landscape of stakeholders, and still collaborate effectively.
- Within and between QARA functions in China
- Together with business functions in china, such as legal, finance, commercial
- Together with Global business and QARA leaders
- Excellent communication (both written and verbal), influence and negotiating skills.
- Pinpoint communication of complex regulatory information to a wide variety of audiences and stakeholders.
- Strong reflexes in stakeholder management and buy in and consensus building.
- Can-Do attitude with an emphasis on delivering results in an effective and collaborative manner
- Strong leadership of people and organization, placing critical importance on development of employees.
- Critical thinker able to address complex situations and issues, and articulate a path forward.
- Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings.
- Develop strategic goals and objectives from knowledge base and understanding of a customer's business.
- Manage changing conditions, processes and approaches; lead organizations through change effectively.
- Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
- Advanced educational degree in medical science, core science, or engineering.
- 15 Years of work in CFDA Registration and Clinical Trials for Medical Devices.
- Strong participation in CFDA compliance, including GXP, audits, and inspection management
- Work in a medical device or comparable environment with working knowledge of sound methods for control of documents and records.
- Experience to both large-company work culture and small-company work culture.
- Familiarity with a wide variety of PLM practices and procedures