Current jobs related to Quality Management Systems and Regulatory Affairs Manager - Bedford, Bedford - Werfen

  • Regulatory Affairs Specialist

    4 days ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, reagents, and data management solutions. With a strong focus on innovation and quality, we provide healthcare professionals with valuable and complete solutions to improve hospital efficiency and enhance patient care. Our...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Job Title: Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.About the RoleWe are looking for a highly skilled and motivated individual to lead the development and...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Job Title: Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.About the RoleWe are looking for a highly skilled and motivated individual to lead the development and...

  • Regulatory Affairs Specialist

    1 week ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, reagents, and data management solutions for hospitals and clinical laboratories. Our business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. We prioritize...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging. We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, with a focus on labeling and promotional communications. The successful candidate will be...

  • Quality Assurance Manager

    1 month ago

    Bedford, Bedford, United Kingdom CURE TALENT LIMITED Full time

    Quality Systems Manager OpportunityCure Talent is delighted to partner with a global leader in medical diagnostics and IVD products. Their reputation for delivering accurate, user-friendly solutions that empower individuals to take control of their health is second to none.The company is seeking an experienced Quality Systems Manager to join their highly...

  • Quality Assurance Manager

    1 month ago

    Bedford, Bedford, United Kingdom CURE TALENT LIMITED Full time

    Quality Systems Manager OpportunityCure Talent is delighted to partner with a global leader in medical diagnostics and IVD products. Their reputation for delivering accurate, user-friendly solutions that empower individuals to take control of their health is second to none.The company is seeking an experienced Quality Systems Manager to join their highly...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job Summary:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Werfen. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to...

  • Regulatory Affairs Specialist

    1 month ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.Key Responsibilities:Develop and implement regulatory strategies for advertising and promotional materials,...

  • Regulatory Affairs Specialist

    1 month ago

    Bedford, Bedford, United Kingdom Lantheus Medical Imaging Inc Full time

    Regulatory Affairs SpecialistLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and patient care. We are seeking an experienced Regulatory Affairs Specialist to join our team.Key Responsibilities:Develop and implement regulatory strategies for advertising and promotional materials,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job Summary:Werfen is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.Key Responsibilities:Participate in design and risk management teams to provide guidance on regulatory...

  • Regulatory Affairs Specialist

    6 days ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfen, a global leader in diagnostic instruments, seeks a highly skilled Regulatory Affairs Specialist to join our team. This role will focus on ensuring compliance with regulatory requirements for our medical devices in international markets.Key ResponsibilitiesDevelop and implement regulatory strategies to satisfy NMPA and PMDA...

  • Regulatory Affairs Specialist

    4 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Regulatory Affairs team at Werfen, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    4 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Regulatory Affairs team at Werfen, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    3 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    4 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Regulatory Affairs Specialist

    4 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a strong understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international...

  • Program Manager I

    2 weeks ago

    Bedford, Bedford, United Kingdom Werfen Full time

    OverviewWerfenWerfen is a leading global company in the field of specialized diagnostics, with a strong presence in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our innovative approach and commitment to quality have enabled us to become a trusted partner for healthcare professionals worldwide.Job Summary:We are...

Quality Management Systems and Regulatory Affairs Manager

2 months ago

Bedford, Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen is a leading global company in the specialized diagnostics industry, with a strong presence in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our innovative approach and commitment to quality have enabled us to become a worldwide leader in our field. With a global footprint of over 30 countries and a workforce of more than 7,000 employees, we are dedicated to providing healthcare professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Global Quality Assurance and Regulatory Affairs Systems Manager is a key role within our organization, responsible for providing leadership and strategic direction to develop and implement a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems. This position requires collaboration with QA/RA partners, IT teams, and external vendors to design and implement efficient processes and workflows, ensuring continuity and successful delivery of functional services to users throughout the organization.

Responsibilities

  • Develop and implement a global strategy for the overall eQMS platforms, ensuring alignment with business objectives and regulatory requirements.
  • Leverage synergies between processes and workflows in different Technology Centers, promoting standardization and harmonization to optimize system performance.
  • Lead the Digital Board QARA meetings from the QA/RA perspective, ensuring effective communication and collaboration with stakeholders.
  • Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems, ensuring both process and system requirements are fully identified, evaluated, tested, and implemented.
  • Identify opportunities for process improvement, automation, application operational efficiency, and security, and implement solutions to address these areas.
  • Identify and troubleshoot system issues, working with IT, partners, and vendors to resolve these issues in a timely manner.
  • Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders, ensuring effective communication and collaboration.
  • Work with leadership at various Werfen Technology Centers to ensure timely implementation and delivery of new functionality and enhancements.
  • Work with stakeholders within QARA at Werfen Technology Centers to create, update, and oversee processes and workflows for eQMS systems, implementing timely updates as changes occur.
  • Assist with data analytics and reporting capabilities, ensuring systems are optimized to reduce manual reporting and improve data-driven decision-making.
  • Drive the definition of business rules for platform governance, processes, and procedures, ensuring alignment with regulatory requirements and business objectives.
  • Manage eQMS supplier relationships, ensuring effective collaboration and communication to meet business needs.
  • Create and execute a strategy to ensure that local eQMS stakeholders are trained and equipped to use the system effectively.

Networking/Key relationships

  • Corporate QA/RA Team
  • Digital Board QA/RA Team
  • IT Leads and teams
  • Global Systems Analyst
  • QA/RA leadership at Werfen Technology Centers and teams
  • Key stakeholders across the organization

Qualifications

Minimum Knowledge & Experience required for the position:

  • Bachelor's degree preferably in STEM, Information Systems, or Business
  • Minimum of 5 years of directly related experience with implementing and maintaining enterprise eQMS platforms
  • Minimum of 5 years of directly related experience with QMS
  • Additional Skills/Knowledge: IT Systems Project Management, Language: English (fluent), Spanish (basic)

Skills & Capabilities:

  • Well-developed leadership skills
  • Strong verbal and written communication skills, with the ability to present complex information in an easily consumable manner
  • Ability to build relationships within Werfen departments
  • Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders
  • Robust organizational skills
  • Excellent time management skills, with proven ability to meet deadlines
  • Strong analytical and problem-solving skills
  • Advanced understanding of database construction and configuration
  • Good computer skills and proficiency with QA/RA systems
  • Ability to effectively champion the project to completion through constant interaction with peers and senior leadership in a professional manner
  • Ability to evaluate issues and new requirements to assess impact to the product and/or business
  • Ability to accept and act on constructive criticism
  • Demonstrates negotiation skills for conflict resolution
  • Be a high-energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people

Travel requirements:

  • Up to 25% travel, domestic and international