Complaints Resolution Specialist

6 days ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

Job Title: Complaints Resolution Specialist

Location: Oxford, UK (with up to 20% travel)

Overview:

A pioneering medical technology company is seeking a motivated Complaints Resolution Specialist to join its global expansion team. This exciting opportunity allows you to work in a fast-paced, innovative environment committed to enhancing patient outcomes.

The Complaints Resolution Specialist will ensure compliance with internal requirements and domestic/international regulations regarding complaint handling. Key responsibilities include managing regulatory activities related to complaints reporting, field corrective actions, quality systems processes, training materials, and controls supporting medical device reporting and field corrective actions in accordance with established agency regulations.

Main Responsibilities:

  • Establish a forward-thinking vision for complaint handling, aligning team objectives with overall company strategy and industry best practice.
  • Lead staff responsible for initiating complaints and ensuring all required information is added to the complaints file in an accurate and timely manner.
  • Communicate professionally with customers and field representatives to gather additional complaint information as warranted.
  • Support service and repair events, including evaluation of intake information, review of repair activities to assess whether a complaint is warranted, and facilitation of device returns.
  • Collaborate globally on projects as needed.
  • Lead continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting, and Risk Management Systems.
  • Support internal and external audits.
  • Evaluate assigned complaint metrics, such as achieving target times for complaint reporting or completion.
  • Assist with staff training to ensure compliance with Complaints/Post Market Surveillance requirements.
  • Prepare reports on complaint trending, metrics, post market surveillance activities, Periodic Safety Reports, etc.
  • Ensure regulatory guidance documents are available prior to product launch in all jurisdictions and capture applicable Post Market Surveillance activities.
  • Complete reportability assessments and route for approvals in a timely manner.
  • Submit adverse event/vigilance reports to relevant authorities as necessary.
  • Prioritize complaints based on patient, product, and compliance risk.

About the Role:

This challenging role requires a highly skilled individual who can drive effective complaint handling practices, ensuring compliance with regulatory requirements and fostering a culture of excellence within the organization.

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field (Master's preferred).
  • Minimum 5 years of experience in quality assurance, complaints handling.
  • In-depth knowledge of FDA, ISO 13485, and EU MDR regulations regarding complaint handling.
  • Experience with communication to local authorities (e.g., FDA, Health Canada) preferred.
  • CAPA process knowledge preferred.
  • Internal auditor training a plus.
  • Working knowledge of FDA processes for medical device compliance.
  • Familiarity with EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM.

Estimated Salary Range: £60,000 - £80,000 per annum, depending on qualifications and experience.



  • Oxford, Oxfordshire, United Kingdom Tripadvisor Full time

    About the RoleWe are seeking a highly skilled Customer Service Representative to join our team as an Escalation Resolution Specialist. In this role, you will be responsible for supporting our customers by resolving their queries through phone, chat, and email contacts.As an Escalation Resolution Specialist, you will utilize various software tools to navigate...


  • Oxford, Oxfordshire, United Kingdom TripAdvisor LLC Full time

    At TripAdvisor LLC, we're committed to providing exceptional customer experiences. As an Account Resolution Specialist, you'll play a critical role in ensuring our customers receive top-notch support.About the JobWe're seeking a highly skilled and motivated individual to join our team as an Escalation Resolution Associate. This is a fantastic opportunity to...


  • Oxford, Oxfordshire, United Kingdom Tripadvisor Full time

    About the RoleAs a valued member of our customer support team, the Escalation Resolution Associate will play a critical role in ensuring the highest level of satisfaction for our customers. This position requires a customer-focused individual with excellent communication skills, who can effectively resolve complex customer issues through various...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    OrganOx seeks a skilled Regulatory Compliance Specialist to oversee the regulatory activities of the company. The ideal candidate will have a proven track record in working within the NHS and regulatory compliance with MDR 2017/745 and Medical Device Regulation 2002. Key responsibilities will include working with the Global Quality Manager to ensure...

  • Litigation Solicitor

    2 weeks ago


    Oxford, Oxfordshire, United Kingdom Ashville Knight Full time £43,000 - £70,000

    Senior Dispute Resolution Specialist OpportunityA dynamic and ambitious Litigation Solicitor is sought by Ashville Knight to join their esteemed Legal 500 firm in Oxford. The successful candidate will have a good understanding of the market, enabling them to take on an existing varied caseload while undertaking business development.About the Role:Manage a...


  • Oxford, Oxfordshire, United Kingdom Industry Placements Full time

    Logistics Quality Assurance SpecialistIndustry Placements is seeking a skilled Logistics Quality Assurance Specialist to join our Logistics department. In this role, you will be responsible for managing daily tasks, including complaint reports and 8D reports, while maintaining databases of supplier contacts and SCQ activities.This is an excellent opportunity...


  • Oxford, Oxfordshire, United Kingdom Industry Placements Full time

    Industry Placements: A Leading Provider of Industry PlacementsAt Industry Placements, we pride ourselves on providing high-quality industry placements for students and graduates. Our aim is to equip our participants with the skills and knowledge needed to succeed in their chosen careers.Our Logistics department plays a critical role in ensuring the smooth...


  • Oxford, Oxfordshire, United Kingdom Tripadvisor Full time

    About UsTripadvisor is the leading travel platform for travel experiences. We believe that making memories is what travel is all about. Our platform offers 300,000+ travel experiences to explore, from simple tours to extreme adventures. With industry-leading flexibility and last-minute availability, it's never too late to make any day extraordinary.Perks of...


  • Oxford, Oxfordshire, United Kingdom Industry Placements Full time

    Supply Chain Quality Management OpportunityRolls-Royce Motor Cars, a part of the BMW Group, is seeking a talented individual to join its Supply Chain Quality team as an intern.The successful candidate will be responsible for managing daily tasks within the Supply Chain Quality team, including the distribution and resolution of Complaint Reports and 8D...


  • Oxford, Oxfordshire, United Kingdom Oxford Health NHS Trust Full time

    About the RoleData-driven and recovery-focused occupational therapist to lead the delivery of evidence-based interventions in a dynamic crisis resolution team. The role involvesdefining and refining the occupational therapy pathway within the teamproviding clinical leadership to junior staffmanaging risk in the least restrictive waycollaborating with...


  • Oxford, Oxfordshire, United Kingdom Oxford Health NHS Trust Full time

    Job SummaryWe are seeking an experienced Occupational Therapist to take on a Clinical Lead role within our Crisis Resolution Team. As a key member of the team, you will play a crucial part in developing and delivering occupational therapy services to individuals in crisis.Key Responsibilities:Develop and implement occupational therapy pathways in...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    At OrganOx, we're revolutionizing organ transplantation with our cutting-edge normothermic machine perfusion technology. Our team is dedicated to preserving donor livers for up to 24 hours, reducing discard rates and improving transplants.We're seeking a highly motivated Medical Device Compliance Specialist to join our fast-paced medical device company. As a...


  • Oxford, Oxfordshire, United Kingdom Tripadvisor Full time

    About the RoleAs an Escalation Resolution Associate at Tripadvisor, you will be the voice of our company, delivering exceptional customer service and ensuring customer satisfaction.Key ResponsibilitiesSupport customers through phone, chat, and email, resolving their queries in a timely and professional manner.Utilize software tools to navigate customer...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    ABOUT ORGANOXWe are a leading medical device company dedicated to improving transplantation outcomes. Our innovative technology helps preserve donor livers, reducing organ discard rates and facilitating successful transplants.SALARY: $65,000 - $80,000 per year, depending on experience and qualifications.JOB DESCRIPTIONThe position of Medical Device...


  • Oxford, Oxfordshire, United Kingdom New Recruits Professional Services Ltd Full time

    Oxford Team Leadership SpecialistWe are seeking a highly skilled Oxford Team Leadership Specialist to join our team at New Recruits Professional Services Ltd in Oxford. This is an exciting opportunity to lead and manage a high-performing team, overseeing project coordination, team management, and quality assurance in a fast-paced automotive manufacturing...


  • Oxford, Oxfordshire, United Kingdom CERCO LTD Full time

    Career Opportunity: Field Service SpecialistCERCO LTD is seeking a skilled Field Service Specialist to work in a variety of settings around the M4 Corridor. This is an excellent opportunity to gain experience and develop your skills in a fast-paced environment.Key Responsibilities:Install and resolve IT equipment at customer sites.Collaborate with the IT...

  • Clinical Team Lead

    1 month ago


    Oxford, Oxfordshire, United Kingdom Oxford Health NHS Foundation Trust Full time

    We are seeking a highly skilled and ambitious clinician to join our team as a Clinical Team Lead. The successful candidate will play a crucial role in shaping our service and ensuring that care is provided in the least restrictive environment possible.The Oxford CRHTT operates in the community seven days a week, providing urgent care for individuals aged...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    About OrganOx:OrganOx is a leading medical device company dedicated to transforming organ transplantation through innovative technologies. Our flagship product, the OrganOx metra, utilizes normothermic machine perfusion to preserve donor livers for up to 24 hours, reducing discard rates and improving transplant success.We are seeking a highly motivated...


  • Oxford, Oxfordshire, United Kingdom NHS Full time

    Oxford Health is seeking a Clinical Lead to join our Crisis Response and Home Treatment Team in Oxford Mental Health Services. As a key part of the Urgent Care Pathway, this role will play a crucial part in meeting the demands of the Ten-Year Plan.The ideal candidate will have a good knowledge of community services, both generic and mental health, and...


  • Oxford, Oxfordshire, United Kingdom Tripadvisor Full time

    About ViatorViator, a Tripadvisor company, is revolutionising travel by making it easy for millions of travellers to find and book experiences they love. With an industry-leading selection of high-quality experiences, Viator gives people something new to discover, both near and far from home.We believe that together, we can achieve great things. Our...