保存工作 返回搜索结果 职责描述 职位概要 类似职位 Own global Quality and Regulatory strategy across multiple regions. Lead an international team in supporting QA & RA. 关于我们的客户 Our client is an international medical technology company, serving healthcare and laboratory customers across multiple regions worldwide. The organization develops and commercializes specialized healthcare solutions and operates within a highly regulated environment with a strong focus on quality, compliance, innovation, and continuous improvement. 职责描述 1. Quality Assurance LeadershipServe as the senior management representative for Quality Assurance activities.Lead the maintenance, enhancement, and effectiveness of the global Quality Management System in accordance with ISO 13485 and applicable medical device regulations.Oversee internal and external audit programs and ensure organizational readiness for regulatory inspections and certification audits.Drive supplier quality management programs, including qualification, monitoring, performance evaluation, and continuous improvement initiatives.Provide leadership for CAPA, change control, complaint handling, non-conformance management, and risk management processes.Ensure compliance with established procedures, policies, and quality standards across the organization.2. Regulatory Affairs LeadershipDevelop and execute global regulatory strategies to support product registration and ongoing compliance across multiple markets.Act as a key regulatory advisor to leadership and cross-functional teams throughout the product lifecycle.Provide oversight and guidance to regional distributors, agents, and local regulatory partners on registration activities.Lead interactions with regulatory authorities, notified bodies, and external stakeholders.Review and approve regulatory submissions, technical documentation, and product development documentation.Support the integration of regulatory requirements into business processes and quality systems.3. Global Team ManagementLead, develop, and mentor an international QARA team based in Sydney.Build a high-performance culture focused on accountability, compliance, collaboration, and professional growth.Coordinate effectively with global stakeholders across R&D, Operations, Supply Chain, Manufacturing, Commercial, and Service functions. 理想的求职者 1.Bachelor's degree in Life Sciences, Engineering, Biomedical Engineering, Regulatory Affairs, Quality, or a related discipline.2.Minimum 10 years of Quality Assurance and Regulatory Affairs experience within the medical device industry, including leadership responsibilities.3.Demonstrated experience managing both QA and RA functions at a global or regional level.4.Solid understanding of medical device regulations and regulatory submissions in major international markets.5.Proven experience supporting CE Mark activities under EU MDR and working directly with Notified Bodies. FDA regulatory experience and exposure to U.S. market will be a plus.6.Experience in BSI or other Notified Body audits and regulatory inspections.7.Demonstrated experience managing cross-country or international direct reporting teams.8.Fluent English communication skills, with the ability to engage effectively with global stakeholders and senior leadership. 薪酬待遇 Great opportunity to take a Global QA & RA Leadership role. 联系 Chris Qu 职位编号 JN-092026-7106740 联系电话 +86 21 6035 3502 职位概要 职位类别 生命科学 子类别 法规事务 行业 医疗保健/制药 地区 苏州市 工作类型 全职 顾问名字 Chris Qu 顾问电话号码 +86 21 6035 3502 职位编号 JN-092026-7106740
