Regulatory Compliance Coordinator

7 days ago


Suzhou, Jiangsu, China Phillips-Medisize Full time

Job Summary:

Phillips-Medisize is seeking a Quality Account Manager to serve as the key quality contact for strategic customers involving multiple manufacturing locations and development centers. This role will support our platform business from Design and Development through Commercialization.

Key Responsibilities:

Design & Development Stage

  • Coordinate the transfer of quality requirements from customer to development team.
  • Coordinate the transfer of quality requirements and documentation from Development centers to multiple Phillips-Medisize manufacturing locations and ensure all quality deliverables from manufacturing locations meet the requirements during Design & Development stages.
  • Coordinate with the Regulatory Affairs team to facilitate alignment and address any gaps.

New Product Introductions (NPI) & Commercial Production Stages

  • Coordinate the NPI processes for quality areas by utilizing resources from different quality organizations in multiple Phillips-Medisize manufacturing facilities producing for shared strategic customers.
  • Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, function as principal quality liaison between Phillips-Medisize facilities and the strategic customer, responding appropriately to internal and external customer needs.
  • Negotiate, review, and approve quality agreements and other quality requirements from strategic customers in collaboration with the appropriate Phillips-Medisize manufacturing facilities.
  • Participate in regular business reviews supplying quality updates on behalf of all Phillips-Medisize facilities producing for the strategic customers.
  • Track and report quality improvement initiatives and action items for the strategic customers.
  • Participate in post-market changes, feedback, and complaints, as well as reporting to authorities by the manufacturing locations and regional RA representatives.
  • Coordinate with internal Regulatory Affairs teams or external RA consultants to ensure registration and post-market regulatory activities are met for various global jurisdictions/markets.

Required Qualifications:

Education:

  • B.S. or Master's degree in engineering or technical field with a minimum of 5 years of related experience.

Skills and Abilities:

  • Leadership skills, including the ability to maintain confidentiality and drive projects and new business processes.
  • Business insights and strategic thinking, including the ability to manage top pharma company expectations.
  • Strong stakeholder management skills.
  • Embracing diversity (culture and personality).
  • Demonstrated superior communication, teamwork, and organizational skills.
  • Ability to develop and meet project/program schedules, along with contingency plans.
  • Ability to travel to customers or manufacturing sites at least 10% of the time.


  • Suzhou, Jiangsu, China Koch Engineered Solutions Full time

    Your Role Koch Engineered Solutions is looking for an Environmental Health and Safety Coordinator to develop and update EHS protocols in compliance with applicable laws and regulations. Key Responsibilities Regularly assess relevant regulatory obligations and assist in the development and revision of EHS protocols to ensure compliance with applicable...


  • Suzhou, Jiangsu, China 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. Full time

    Job SummaryWe are seeking a highly skilled Quality Compliance Specialist - Medical Device to join our team at 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. in Suzhou, China. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements and industry standards for medical devices.Key...


  • Suzhou, Jiangsu, China Pfizer Full time

    Resolution of Product Quality Compliance Issues Deviation Management: Ensure closure of any investigations, out-of-specifications, change controls, complaints, and other quality-related matters throughout the production process from all associated manufacturing sites. Execute reviews and ensure any associated deviations are managed and closed within the...


  • Suzhou, Jiangsu, China Danaher Full time

    About DanaherDanaher is a global science and technology leader that brings together exceptional companies with a shared passion to create a brighter, healthier, and more sustainable world. Our portfolio of world-class brands is united by a common purpose: to help our customers solve complex challenges and improve the lives of people around the world.Our...


  • Suzhou, Jiangsu, China HSBC Full time

    The Manager of Consumer Rights Protection plays a pivotal role in supporting the Chief Operating Officer (COO) in developing and sustaining a robust governance framework dedicated to consumer rights protection at HSBC Life Insurance Company Limited. We are looking for a seasoned professional to enhance our team. Key Responsibilities: • Establish...


  • Suzhou, Jiangsu, China Roche Full time

    Position Overview Role Summary: This role is situated within the DIA Manufacturing IT team and is tasked with ensuring that all systems under IT jurisdiction adhere to compliance standards for Roche Diagnostics. The compliance focus encompasses GxP regulated computerized systems and the security of site IT infrastructure. Key Responsibilities: 1....


  • Suzhou, Jiangsu, China Bosch Group Full time

    Job DescriptionJob Summary: We are seeking a highly skilled Internal Control Specialist to join our team at the Bosch Group. As an Internal Control Specialist, you will be responsible for implementing effective internal control systems and ensuring compliance with regulatory requirements.Key Responsibilities:Develop and implement internal control systems to...


  • Suzhou, Jiangsu, China 821 GlaxoSmithKline Philippines Inc Full time

    The Compliance Manager for the Philippines is responsible for collaborating with the General Manager and senior management to support the organization in achieving its commercial objectives while ensuring adherence to regulatory standards. This role involves influencing appropriate conduct, promoting accountability, and nurturing leadership that fosters a...

  • Compliance Officer

    7 days ago


    Suzhou, Jiangsu, China Reckitt Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Reckitt. As a Quality Assurance Manager, you will be responsible for ensuring the highest standards of quality and compliance within our supply and distribution chains.About the RoleThis is an exciting opportunity to join a global team united by a shared purpose: to...


  • Suzhou, Jiangsu, China Danaher Full time

    Position OverviewAs a key player in our logistics team, you will be responsible for the effective management of materials within our warehouse environment. Your role will involve:Receiving and Verifying Materials: You will oversee the receipt of raw materials and packaging supplies, ensuring accurate counts and confirming discrepancies before...


  • Suzhou, Jiangsu, China Danaher Full time

    **Job Summary**At Danaher, we are seeking a highly skilled and detail-oriented individual to join our team as a Technician Shipping/Receiving. This role is responsible for ensuring the smooth flow of goods and materials within our warehouse, from receiving and storing to shipping and delivery.**Key Responsibilities:**Receive and inspect incoming shipments,...


  • Suzhou, Jiangsu, China Pfizer Full time

    Resolution of Product Quality Compliance Issues Deviation Management: Ensure closure of all investigations, out-of-specifications, change controls, complaints, and any other quality-related matters throughout the production process from all associated manufacturing sites. Execute reviews and ensure that any associated deviations are managed and closed...


  • Suzhou, Jiangsu, China HSBC Full time

    The Manager of Consumer Rights Protection plays a crucial role in supporting the Chief Operating Officer (COO) in developing and sustaining a robust governance framework dedicated to consumer rights protection for HSBC Life Insurance Company Limited. We are in search of a seasoned professional to enhance our team. Key Responsibilities: • Establish...


  • Suzhou, Jiangsu, China Philips Full time

    Job title:CS Training CoordinatorYour role: Assist sales or training specialists with arranging training for hospitals or distributors under compliance principles. Communicate with suppliers to arrange training details. Collecting training records of the students. Submitting expense applications and distributing costs. Contacting customers and business...


  • Suzhou, Jiangsu, China Philips Full time

    Job TitleCS Training CoordinatorJob DescriptionJob title:CS Training CoordinatorYour role:Assist sales or training specialists with arranging training for hospitals or distributors under compliance principles.Communicate with suppliers to arrange training details.Collecting training records of the students.Submitting expense applications and distributing...


  • Suzhou, Jiangsu, China Roche Full time

    Position Overview Main Responsibilities:1. Oversee and coordinate the monitoring of external regulatory standards, ensuring that stakeholders are informed and compliance assessments are conducted to develop mitigation strategies. Prepare and review process documentation, considering the various factors affecting the involved functional areas and in line with...


  • Suzhou, Jiangsu, China Roche Full time

    Position Overview Key Responsibilities:1. Oversee and coordinate the monitoring of external regulatory standards, ensuring that stakeholders are informed and compliance assessments are conducted for the development of mitigation strategies. Prepare and review process documentation while considering the influencing factors across functional areas in alignment...


  • Suzhou, Jiangsu, China Pfizer Full time

    Resolution of Product Quality Compliance Issues Deviation Management: Ensure closure of all investigations, out-of-specifications, change controls, complaints, and any other quality-related matters throughout the production process across all relevant manufacturing sites. Execute reviews and ensure management and closure of any associated deviations within...


  • Suzhou, Jiangsu, China HSBC Full time

    The Manager of Consumer Rights Protection plays a crucial role in supporting the Chief Operating Officer (COO) in developing and sustaining a robust governance framework for consumer rights protection at HSBC Life Insurance Company Limited. We are looking for a seasoned professional to enhance our team. Key Responsibilities: • Establish and uphold...


  • Suzhou, Jiangsu, China eChinaCareers Full time

    About the RoleWe are seeking a highly skilled and experienced Primary Years Programme (PYP) Coordinator to join our team at eChinaCareers. This is a full-time position that will play a crucial role in supporting teachers, guiding curriculum development, and enhancing educational standards to provide a comprehensive and engaging learning environment for...