Regulatory Affairs/Quality Assurance Manager

POSITION SUMMARY:

The Chinese Regulatory Affairs/Quality Assurance Manager provides oversight of regulatory submissions to obtain and maintain marketing privileges consistent with applicable Chinese government requirements. This position’s duties also includes those of the AtriCure China Legal Agent. This position will prepare and submit submissions to NMPA to support business growth. The position will serve as regulatory representative for China to monitor regulation changes and formulating regulatory strategies for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals. This position will be responsible for the development, implementation and conformity of the AtriCure quality management system at the Chinese office, including coordinating and managing internal and external audits.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Act as the Legal Agent for AtriCure China and meet the requirements for a Legal Agent outlined in State Council Order 739.
• Develop and maintain positive relationships with NMPA (formerly SFDA, CFDA) and other regulatory authorities.
• Develop regulatory strategies, plan and communicate to commercial team and AtriCure, Inc.
  • Develop strategy and negotiate with the regulatory authorities, prepare and track submissions
• Liaise with NMPA in regulatory submissions, proposals, analysis and submission of change notifications and provide timely response to input requests
• Participate in / coordinate additional project assignments as determined by the Sr. Manager of Regulatory Affairs
• Organize Regulatory Committee meetings with AtriCure China Sales and Marketing Teams and follow up agreed actions to ensure timely support to business focuses
• Provide required Regulatory information regarding AtriCure products in support of provincial licensing and hospital tenders and support of other key regional initiatives
• Act as the Quality Assurance Manager for AtriCure China, including but not limited to:

• • Develops, implements and maintains an effective quality management system in accordance with applicable regulatory requirements and aligned with ISO 13485 and YY / T 0287-2017.
  • Ensures AtriCure is in a consistent state of conformity with the applicable regulatory requirements.
  • Audits key distributors for conformity with applicable regulatory requirements and the distribution agreement.
  • Reports to the management of the Chinese office on the effective implementation of the quality management system.
  • Ensures that product complaints and incidents are reviewed, investigated and reported, as applicable.
  • Ensures that product field safety corrections, including recalls, are implemented without delay.
  • Remains industry-current through professional, technical or other societies.

BASIC QUALIFICATIONS:

• Bachelor’s (University) degree required in a technical/scientific discipline (engineering, medicine, , chemistry, pharmacy, nursing, etc.)
• A minimum of 3 years of working experience in a medical device quality management system role.
• A minimum of 5 years working experience in a regulatory affairs management role, mainly for medical device companies
• Established record of developing and maintaining relationships with regulatory reviewers and inspectors
• Experience with type testing laboratories
• Must have recent working knowledge of Chinese medical device regulations and standards
• Experience in preparing regulatory submissions and as a Legal Agent
• Business proficiency in spoken and written English and Mandarin
• Ability to work and collaborate with both internal and external stakeholders.
• Ability to manage multiple projects and registrations
• Must demonstrate good technical writing skills and demonstrate good communication skill in team setting
• Must be eligible for a Visa to travel to US/EU
• Ability to travel 20-25%

PREFERRED QUALIFICATIONS:

• Submission experience with NMPA for Class III cardiovascular devices