Medical Device Compliance Specialist

21 hours ago


Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

HealthHero Group is a digital-first, end-to-end healthcare provider connecting smart digital tools with gold-standard clinical expertise to enhance people's whole health and optimize healthcare efficiency.

We are seeking a highly experienced Clinical Governance and Regulatory Expert to work in our Clinical Product Team. As a key member of the team, you will provide support and guidance on all aspects of Product Quality, Compliance & Governance.

  • This role involves acting as a Business Partner for the relevant Department/Business Area, with specific focus on Medical Device regulations.
  • You will be responsible for managing the quality and compliance of the whole product lifecycle, including compliance and maintenance of relevant standards and certifications.

The estimated salary for this position is around $70,000 - $90,000 per annum, depending on experience.

Responsibilities:
  • Chair relevant meetings and committees as required as part of the Quality Management System.
  • Lead the process of transitioning our Class 1 Medical Devices to Class 2a under the EU MDR framework, acting as the point of contact with the Notified Body.
  • Leading preparations for ISO13485 audits and working with the Governance Team to ensure that our certified quality management system is maintained throughout the year.

Requirements:

  • Knowledge and experience of quality management and the governance of medical devices within an ISO 13485 accredited healthcare organization.
  • Desirable – have experience of software as a medical device including MDR submissions.
What We Offer:
  • Company Pension scheme.
  • Access to HealthHero Group healthcare services, including Private 24/7 GP service and Employee Assistance Programme.
  • 25 days holiday + 8 days bank holiday and an extra day off for your birthday.
  • Electric Car scheme.
  • Cycle to work scheme.


  • Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

    As a Quality and Compliance Manager at HealthHero Group, you will play a vital role in ensuring the highest standards of product quality, compliance, and governance across our organization.Our Clinical Product Team is responsible for developing and delivering innovative digital-first healthcare solutions that connect patients with gold-standard clinical...


  • Bracknell, Bracknell Forest, United Kingdom Chemistree Solutions Limited Full time

    Job Title: Medical Territory Sales RepresentativeJob Description:Chemistree Solutions Limited is seeking a highly skilled Medical Territory Sales Representative to join our team in the UK. As a key member of our sales team, you will be responsible for driving sales growth and expanding our market share in the urology sector.Key Responsibilities:Develop and...


  • Bracknell, Bracknell Forest, United Kingdom Lifelancer Full time

    We are seeking a highly motivated and organized Medical Information Specialist to join our team. This is an excellent opportunity for individuals who want to gain a rounded experience of Medical Information and Medical Affairs services.**Job Overview:**The successful candidate will work within the Medical Affairs Transformation and Operations (MATO) team,...


  • Bracknell, Bracknell Forest, United Kingdom Lifelancer Full time

    Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT, offers an exciting opportunity for a Medical Information Specialist to join our team.As a Medical Information Specialist at Lifelancer, you will gain a comprehensive understanding of Medical Affairs services and regulatory environments. You will be part of a supportive team, learning from...


  • Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

    HealthHero Group is a pioneering digital-first healthcare provider, connecting innovative digital tools with gold-standard clinical expertise to revolutionize patient care and optimize healthcare efficiency. With operations in the UK, Ireland, France, and Germany, our mission is to simplify healthcare and enhance lives.We are seeking an experienced Quality...


  • Bracknell, Bracknell Forest, United Kingdom HealthHero Full time

    HealthHero, a leading European healthcare provider, seeks an experienced Regulatory Quality Expert to join its Clinical Product Team. This exciting opportunity will challenge you to develop and implement effective quality management systems that meet the evolving needs of our business.We are seeking a highly skilled individual who possesses in-depth...


  • Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

    Are you a quality professional looking for a new challenge? Do you have experience in quality management and medical device governance within an ISO 13485 accredited healthcare organization?We are seeking a skilled Quality and Compliance Manager to join our Clinical Product Team at HealthHero Group. In this role, you will:Provide expert guidance on product...

  • Paramedic Specialist

    3 weeks ago


    Bracknell, Bracknell Forest, United Kingdom Ringmead Medical Practice Full time

    We are seeking a skilled Paramedic Specialist to join our team at Ringmead Medical Practice. The successful candidate will be a qualified Paramedic with a passion for delivering high-quality patient care.As a Paramedic Specialist, you will work closely with our multidisciplinary team to provide comprehensive care to our patients. You will be responsible for...


  • Bracknell, Bracknell Forest, United Kingdom Signet Recruitment and Retention Full time

    Job Summary:We are seeking an experienced Compliance and Governance Specialist to join our client's Compliance and Risk Department. As a key member of the team, you will be responsible for ensuring all regulatory requirements are met and providing guidance to the business on technical compliance matters.About the Role:The successful candidate will have a...


  • Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

    We are looking for a highly skilled Quality Assurance Manager to join our Clinical Product Team at HealthHero Group.In this role, you will be responsible for providing support and guidance on all aspects of Product Quality, Compliance & Governance.This role involves acting as a Business Partner for the relevant Department/Business Area, with specific focus...


  • Bracknell, Bracknell Forest, United Kingdom I Love My Job Full time

    A Compliance Specialist is required to join our furniture and interiors brand, focusing on ensuring the compliance of our products. This role will involve working closely with the product development team to guarantee that all products meet current standards.The ideal candidate will have a solid understanding of product development, excellent compliance...


  • Bracknell, Bracknell Forest, United Kingdom Marc Daniels Specialist Recruitment Ltd Full time

    Key ResponsibilitiesThis role will be responsible for formulating and maintaining a comprehensive strategy for managing finance master data, pinpointing essential data elements, and ensuring their accuracy and consistency. Additionally, the incumbent will develop and implement data governance policies, procedures, and standards that align with organisational...


  • Bracknell, Bracknell Forest, United Kingdom Boehringer Ingelheim Pharmaceuticals, Inc Full time

    About the RoleAs a Senior Medical Signatory Business Partner at Boehringer Ingelheim Pharmaceuticals, Inc., you will play a critical role in ensuring the integrity of our promotional and non-promotional activities and materials. This position requires a seasoned professional with expertise in medical governance, risk management, and code compliance to lead...


  • Bracknell, Bracknell Forest, United Kingdom Boehringer Ingelheim Pharmaceuticals, Inc Full time

    Job SummaryWe are seeking a Senior Medical Signatory Business Partner to join our team at Boehringer Ingelheim Pharmaceuticals, Inc. This role offers an exciting opportunity for a seasoned professional with expertise in medical governance, risk management, and code compliance to lead our efforts in ensuring the integrity of our promotional and...


  • Bracknell, Bracknell Forest, United Kingdom CV Library Full time

    At CV Library, we're seeking a highly skilled Fire Safety and Compliance Specialist to join our team. This full-time role is based in Bracknell and offers a competitive salary of £33,973 per year.Job Description:The primary objective of this position is to ensure high levels of customer safety through thorough inspections of communal areas within all...


  • Bracknell, Bracknell Forest, United Kingdom CBS Butler Full time

    Network Design Specialist Role OverviewWe are currently seeking an experienced Network Design Specialist to join our team at CBS Butler. This is an exciting opportunity for a skilled engineer to design and support applications in a dynamic and innovative environment.The ideal candidate will have experience working with VMWare SMARTS, SevOne, and Cisco ISE....


  • Bracknell, Bracknell Forest, United Kingdom Ringmead Medical Practice Full time

    Job OverviewAt Ringmead Medical Group, we are seeking a skilled Clinical Coding Administrator to support our clinical team in assessing medical documents and ensuring accurate coding. This role requires experience in a clinical coding environment and flexibility in undertaking various tasks.Salary InformationThe estimated salary for this position is £25,000...

  • Paramedic Specialist

    3 weeks ago


    Bracknell, Bracknell Forest, United Kingdom Ringmead Medical Practice Full time

    Job SummaryWe are seeking a skilled Paramedic Practitioner to join our team at Ringmead Medical Practice. As a key member of our Primary Care Team, you will be responsible for delivering high-quality patient care and contributing to our commitment to ongoing learning and advancement.Main Duties and ResponsibilitiesClinical Responsibilities- Provide telephone...


  • Bracknell, Bracknell Forest, United Kingdom Brandon James Ltd Full time

    About Us:">Brandon James Ltd is a leading consultancy that collaborates with clients to deliver high-quality results.">Job Role:">">This position requires a Building Control Surveyor and/or Registered Building Inspector to work part-time (1 day/week).">The successful candidate will be responsible for site inspections, design meetings, and ensuring compliance...


  • Bracknell, Bracknell Forest, United Kingdom oilandgas Full time

    Job Description:We are looking for a skilled Health and Safety Manager to join our team at oilandgas in Bracknell. As a key member of our HSE team, you will be responsible for developing and implementing effective HSE management systems, ensuring regulatory compliance, and improving the overall HSE culture within our organization.Responsibilities:Implement...