Current jobs related to Medical Devices Quality Assurance Lead - Guildford, Surrey - MV | MysteryVibe

  • Quality Assurance Manager for Medical Devices

    1 week ago

    Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    MV | MysteryVibe is an award-winning leader in women's & men's health devices, creating clinically proven medical devices that adapt to the user's body & deliver targeted vibrations to address Genito-Pelvic pain, penetration pain, arousal disorder & erectile dysfunction.We are embarking on getting ISO 13485 certification, and we need a talented Regulatory...

  • Biostatistics Lead

    1 month ago

    Guildford, Surrey, United Kingdom Gb Tech Full time

    Job SummaryWe are seeking an experienced Biostatistics Lead - Medical Devices to join our team at Gb Tech. As a key member of our data analytics department, you will be responsible for leading the statistical analysis of clinical studies and ensuring high-quality data models.Key Responsibilities:Lead or contribute to the statistical analysis of clinical...

  • Medical Device Director

    3 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant Biotechs is looking for a Medical Device Director to lead our regulatory affairs function. As a senior leader, you will define regulatory strategies, guide clinical and analytical validation studies, and liaise with regulatory authorities to ensure compliance with international medical device directives and regulations.The ideal...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at MV | MysteryVibe. In this exciting role, you will be responsible for leading the development and implementation of our Quality Management System (QMS) for ISO 13485 certification.As a Senior Quality Assurance Specialist, you will create and manage technical files, SOPs,...

  • Compliance Leader

    2 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant BiotechsJob DescriptionWe are looking for a skilled Medical Device Compliance Specialist to lead our regulatory affairs team. As the Head of Regulatory Affairs, you will be responsible for ensuring our organisation's products meet the required regulatory standards worldwide.Key responsibilities include providing strategic...

  • Medical Device Compliance Specialist

    2 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Singular: Building Brilliant BiotechsOpportunity OverviewWe are seeking a highly experienced Regulatory Affairs Director to join our team in Guildford. This senior leadership role involves overseeing our regulatory affairs strategy, ensuring our organisation meets all relevant regulatory standards across global markets.You will lead the regulatory and...

  • Medical Device Compliance Manager

    2 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Job SummaryWe are seeking a highly experienced Medical Device Compliance Manager to join our team in Guildford. This is an exciting opportunity to lead our regulatory efforts and ensure compliance with global medical device regulations.In this role, you will be responsible for developing and implementing regulatory strategies to support new product...

  • Quality Management Systems Lead

    2 weeks ago

    Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    MV | MysteryVibe is a small but fast-growing medical device business dedicated to improving women's and men's healthcare. We are seeking a Quality Management Systems Lead to join our team and lead the development and implementation of our QMS for ISO 13485 certification.About the JobThis role requires a strong understanding of quality management systems, ISO...

  • Medical Device Regulatory Expert

    2 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    About the OpportunitySingular: Building Brilliant Biotechs is seeking an experienced Head of Regulatory Affairs to join its team in Guildford. As a key member of the team, you will be responsible for ensuring the organisation meets all relevant regulatory standards across global markets. You will provide strategic direction and operational oversight to the...

  • Medical Device Compliance Manager

    2 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Regulatory Compliance SpecialistSingular is looking for a highly skilled Medical Device Compliance Manager to oversee regulatory compliance across the organisation.Estimated Salary: £95,000 - £130,000 per annumAbout the TeamThe regulatory and quality teams work closely together to ensure the organisation meets all relevant regulatory standards.The team...

  • Quality Assurance Lead

    2 weeks ago

    Guildford, Surrey, United Kingdom MEDPHARM LTD Full time

    Job Summary:We are seeking a talented Senior Quality Assurance Specialist to join our team in Guildford. In this role, you will play a critical part in ensuring the quality of our products and driving process improvements across the organization.About MedPharm:MEDPHARM LTD is a global leader in topical and transdermal product development, providing...

  • Scientific Validation Lead

    2 weeks ago

    Guildford, Surrey, United Kingdom Alliance Medical Full time

    Job DescriptionAs a Radiochemist Validation Specialist at Alliance Medical, you will be responsible for supporting the development and implementation of cGMP and Quality Assurance systems.You will assist in staff training and development, develop staff training plans, and collaborate with production and quality teams for corrective actions and root-cause...

  • Regulatory Compliance Specialist

    2 weeks ago

    Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    We are looking for a Quality Assurance Manager for Medical Devices to join our team at MV | MysteryVibe. As a Quality Assurance Manager, you will oversee the development and implementation of our Quality Management System (QMS) for ISO 13485 certification.You will be responsible for creating and managing technical files, SOPs, risk management reports, and...

  • Head of Medical Regulatory Strategy

    3 weeks ago

    Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time

    Key ResponsibilitiesAs our ideal candidate, you will have a strong background in IVD medical device product development and a deep understanding of global medical device directives.You will be responsible for leading our regulatory efforts, developing and implementing regulatory strategies to support new product development and commercialisation.You will...

  • Medical Support Assistant

    2 weeks ago

    Guildford, Surrey, United Kingdom OH Medical Recruitment Ltd. Full time

    Are you looking for a challenging and rewarding role as an Occupational Health Technician?About the Opportunity:This position involves working with a leading occupational health provider in the Guildford area, conducting health surveillance screenings, and ensuring accurate recording of medical information.Key Tasks:Conduct health surveillance...

  • Quality Assurance Specialist

    2 weeks ago

    Guildford, Surrey, United Kingdom RBW Consulting Full time

    We are seeking a skilled Quality Assurance Specialist to join our team in Guildford, UK. As a key member of our quality assurance team, you will play a crucial role in ensuring the validation of high-quality pharmaceutical products.The ideal candidate will have a degree in a life science subject and previous work experience with validation activities. You...

  • Quality Systems Lead Specialist

    2 weeks ago

    Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

    About the RoleThis is an exciting opportunity to join MV | MysteryVibe as we embark on getting ISO 13485 certification. You will be responsible for developing and implementing the QMS for Class II OTC medical devices, creating technical files, SOPs, risk management reports, and other documentation required for ISO 13485 cert.

  • Medical Screening Professional

    4 weeks ago

    Guildford, Surrey, United Kingdom OH Medical Recruitment Ltd. Full time

    Job Opportunity: Medical Screening ProfessionalWe are seeking an experienced Medical Screening Professional to join our team in the Guildford area. As a Medical Screening Professional, you will be responsible for conducting health surveillance screening, recording medical information, and supporting health promotion activities. This is a full-time position...

  • Director of Pharmacy Quality Assurance

    2 weeks ago

    Guildford, Surrey, United Kingdom NHS Full time

    Job DescriptionWe are seeking a highly experienced Director of Pharmacy Quality Assurance to lead our Pharmacy Aseptic Service. The successful candidate will have a strong background in quality management, with experience in a licensed facility and a proven track record of delivering quality services.The role will involve managing all aspects of the...

  • Urologist Medical Consultant

    2 weeks ago

    Guildford, Surrey, United Kingdom ID Medical Full time

    ID Medical is seeking a highly skilled Consultant Urologist to join our team as a Surgical Specialist in Urology.The ideal candidate will have excellent clinical skills and experience in providing urological care and surgery.Job Description:As a Consultant Urologist, you will be responsible for:Providing expert care and surgical services to patients with...

Medical Devices Quality Assurance Lead

2 months ago

Guildford, Surrey, United Kingdom MV | MysteryVibe Full time
Job Description

MV | MysteryVibe is an award-winning leader in women's and men's health devices, creating clinically proven medical devices that adapt to the user's body. We deliver targeted vibrations to address Genito-Pelvic pain, penetration pain, arousal disorder, and erectile dysfunction.

The company offers a competitive salary of $120,000 - $150,000 per year, along with benefits including comprehensive private medical insurance. Our dynamic work environment provides opportunities for growth and professional development, with guidance directly from founders and senior professionals in engineering and medicine.

Position Overview:

We are embarking on getting ISO 13485 certification, requiring the creation and management of necessary documentation and processes. You will lead cross-functional teams across the company and external suppliers to build required documentations and processes for ISO 13485. Your role will be to focus on internal Quality Assurance, ensuring all documentation and processes are up-to-date.

This is a fantastic opportunity for someone looking to have full ownership of Quality assurance and processes in a small and fast-growing medical device business, making a huge impact on women's and men's healthcare.

Key Responsibilities:
  • Lead the development and implementation of the QMS for ISO 13485 certification, particularly for Class II OTC medical devices.
  • Create and manage technical files, SOPs, risk management reports, and other documentation required for ISO 13485 cert.
  • Collaborate closely with product development and manufacturing teams, ensuring alignment with quality and regulatory standards.
  • Serve as the main point of contact for external auditors and certification bodies, receiving guidance from the company's senior leadership.
  • Stay up-to-date on ISO 13485 standards and regulations, ensuring compliance with ongoing post-certification requirements.
  • Perform internal audits and continuous process improvements for ISO 13485 compliance.
  • Train and educate internal teams on quality management processes and regulatory compliance.
  • Work alongside the manufacturing teams to ensure quality and compliance are maintained across the product lifecycle.
Qualifications:
  • 5+ years of experience with medical devices, including OTC devices, QMS, or quality assurance, with a strong interest in developing ISO 13485 expertise.
  • Previous experience working in a startup or small business is a plus.
  • Experience in technical writing and maintaining documentation for medical devices, preferably Class II products, is a plus.
  • Ability to work independently in a fast-paced environment, with excellent project management and problem-solving skills.
  • Strong communication skills, with the ability to collaborate across teams.