Medical Device Lead Auditor for Quality and Regulatory Affairs

3 weeks ago


Shenzhen, Guangdong, China Vision Achievement Full time

Vision Achievement seeks a seasoned Medical Device Lead Auditor to spearhead our quality and regulatory affairs initiatives in China. This exciting opportunity offers the chance to work with a renowned company, utilizing your expertise to ensure compliance with FDA/EUMDR regulations.

Job Description:

The successful candidate will be responsible for planning and delivering audits and consulting engagements related to quality and regulatory affairs infrastructure. This role requires a strong understanding of medical device regulations, including ISO 13485 and MDSAP.

Required Skills and Qualifications:

  • Bachelor's degree in Engineering, Science, or life science-related field
  • Evidence of progressively taking on more responsibility and leading activities in their field
  • Recognized certification as a Lead Auditor for ISO 13485; MDSAP or equivalent
  • Demonstrated experience leading a substantial number of audits under FDA regulations (EU-MDR a plus)
  • Interpretation and application of codes, regulations, and standards in the medical device industry, including GMP

Industry Requirements:

  • At least eight years' experience in medical device or in vitro device manufacturing
  • Experience with quality systems planning and implementation under a recognized life science standard
  • Experience working with a Notified Body is a plus
  • Experience with design control and process validation program development and implementation
  • Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21 CFR Part 820 and/or relevant EU Regulations
  • Experience with any of ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus

Travel:

The ability to travel extensively within China is required, with occasional international travel possible.

Salary: We offer a competitive salary of $120,000 - $180,000 per year, commensurate with experience, to lead this critical role in our organization.



  • Shenzhen, Guangdong, China Vision Achievement Full time

    Job DescriptionVision Achievement seeks a seasoned Medical Device Lead Auditor to lead Life Science audits and consulting engagements in China. This role requires a strong background in quality/regulatory affairs infrastructure, with a focus on FDA/EUMDR compliance.About the RoleThis is an individual contributor position that involves planning and delivering...


  • Shenzhen, Guangdong, China Vision Achievement Full time

    About the RoleVision Achievement is seeking a seasoned Medical Device Auditor to join our team in China. As an Affiliate Lead Auditor, you will play a crucial role in ensuring the quality and regulatory compliance of medical devices.Key ResponsibilitiesPlan and deliver audit engagements related to quality and regulatory affairs infrastructure for medical...


  • Shenzhen, Guangdong, China Vision Achievement Full time

    At Vision Achievement, we are seeking a highly skilled Medical Device Regulatory Compliance Specialist to join our team in China.Job Description:The Medical Device Regulatory Compliance Specialist will play a key role in planning and delivering Life Science audit and consulting engagements related to quality/regulatory affairs infrastructure appropriate to...


  • Shenzhen, Guangdong, China Supply Chain Resources Group Full time

    Job Title: Mechanical SIE Team LeadAbout Us:We are Supply Chain Resources Group, a leading provider of supply chain solutions. Our team is dedicated to delivering exceptional results and exceeding client expectations.Job Description:The Mechanical SIE Team Lead will be responsible for driving quality expectations with carbon fiber vendors and interacting...


  • Shenzhen, Guangdong, China Supply Chain Resources Group Full time

    About UsAt Supply Chain Resources Group, we are a leading provider of supply chain management solutions for the aviation industry.Job DescriptionWe are seeking an experienced Quality Assurance Specialist to join our team. The successful candidate will be responsible for driving quality expectations with mechanical part vendors and ensuring that vendor...


  • Shenzhen, Guangdong, China Arrow Electronics, Inc. Full time

    Job DescriptionAs a Logistics Engineer at Arrow Electronics, Inc., you will play a crucial role in the seamless operation of our global supply chain. This position requires a unique blend of analytical skills and practical knowledge to develop and improve logistics processes.Key Responsibilities:Analyze and improve logistical processes, including...

  • ESL Teacher

    3 days ago


    Shenzhen, Guangdong, China China Global Connections Full time

    We are seeking an experienced ESL Teacher to join our team at China Global Connections, a reputable international school in Shenzhen.Job OverviewAs an ESL Teacher, you will play a vital role in shaping the educational journey of our students. Our school is dedicated to providing a high-quality education that prepares students for success in an increasingly...


  • Shenzhen, Guangdong, China Arrow Electronics, Inc. Full time

    Job SummaryWe are seeking a highly skilled Sales Operations Associate to join our team at Arrow Electronics, Inc. in Shenzhen, China. As a Sales Operations Associate, you will play a vital role in supporting the sales team by implementing and maintaining operational processes that drive business growth.In this dynamic role, you will be responsible for...


  • Shenzhen, Guangdong, China Supply Chain Resources Group Full time

    Supply Chain Resources Group is seeking a highly skilled Mechanical SIE Specialist to join our team.About the RoleWe are looking for an experienced professional to drive mechanical part carbon fiber vendors quality expectations and interact with material planning, new product development and global supply management teams. This role requires strong...


  • Shenzhen, Guangdong, China Supply Chain Resources Group Full time

    About the RoleWe are seeking a skilled Packaging Engineer to join our team at Supply Chain Resources Group. This role will be based in Shenzhen, with frequent travel required to collaborate with international suppliers and teams.Job DescriptionMaintain close collaboration with Asia and US engineering teams to ensure seamless communication and effective...


  • Shenzhen, Guangdong, China Arrow Electronics, Inc. Full time

    Job Title: Learning and Development Specialist - Asia Pacific RegionCompany Overview:Arrow Electronics, Inc. is a leading global provider of products, services, and solutions for industrial and commercial users of electronic components and enterprise computing solutions.Salary:We offer a competitive salary range of $120,000 - $180,000 per annum, depending on...


  • Shenzhen, Guangdong, China Arrow Electronics, Inc. Full time

    About the RoleWe are seeking a skilled Senior Sales Representative to join our team in Shanghai. In this role, you will be responsible for developing strong relationships with customers and identifying new business opportunities.As a key member of our sales team, you will work closely with internal stakeholders to understand customer needs and provide...


  • Shenzhen, Guangdong, China Supply Chain Resources Group Full time

    Job DescriptionWe are seeking a highly skilled Mechanical Supply Chain Specialist to join our team at Supply Chain Resources Group.This is a full-time opportunity with a competitive salary of $120,000 - $150,000 per year, depending on experience.Key Responsibilities:Drive mechanical part quality expectations and collaborate with material planning, new...


  • Shenzhen, Guangdong, China Arrow Electronics, Inc. Full time

    Job DescriptionAt Arrow Electronics, Inc., we are seeking a highly skilled Digital Sales Growth Specialist to join our team. This is an exciting opportunity to grow your sales career with a leading technology company.Key ResponsibilitiesCreate and implement strategic plans to drive sales growth and demand creation for Arrow products and services.Build and...


  • Shenzhen, Guangdong, China Supply Chain Resources Group Full time

    Job OverviewWe are seeking a highly skilled Strategic Administrative Professional to support our Vice President with all administrative duties, including travel coordination, expense claims, meeting arrangements.The ideal candidate will be responsible for organizing team meetings and engagement activities, managing complex calendars and scheduling...


  • Shenzhen, Guangdong, China Eurofins GSC Poland Sp. z o. o. Full time

    Eurofins GSC Poland Sp. z o. o. is seeking a skilled Chemical Test Assistant Specialist to join our team. This role offers an exciting opportunity to work in a dynamic laboratory environment, providing essential support to chemists and scientists.The ideal candidate will have a solid understanding of chemical principles and practices, with at least one year...


  • Shenzhen, Guangdong, China Arrow Electronics, Inc. Full time

    Inventory Management ProfessionalWe are seeking a skilled Materials Planner to join our team at Arrow Electronics, Inc.About the Role:This position involves managing complex inventory demands and optimizing supply chain operations.The ideal candidate will have a strong background in materials planning and inventory management.You will work closely with...

  • Logistic Engineer

    3 days ago


    Shenzhen, China Arrow Electronics, Inc. Full time

    Position:Logistic EngineerJob Description:Logistics EngineerOur Logistics Engineer plays a critical role in the seamless operation of the supply chain. This role employs a blend of analytical skills and practical knowledge to develop and improve logistics processes, and solution implementation in the warehouse.This individual will report to the Director of...


  • Shenzhen, China Commscope Full time

    In our ‘always on’ world, we believe it’s essential to have a genuine connection with the work you do. CommScope is looking to add a Product Engineer to our team in [Shenzhen]. How You'll Help Us Connect the World. Provide leadership and support to assigned product lines as well as support product extensions for new applications. Product lines may...


  • Shenzhen, China Arrow Electronics, Inc. Full time

    Position:Regional System AnalystJob Description:Oracle EBS - Regional System Analyst(亚太区域系统分析师)We are looking for a Regional System Analyst to join Arrow company. The main purpose of the position is to provide multiple regional IT support in Arrow system for Asia Pac users, such as production support, special project implementation support,...