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    • In this role, you’ll deliver internal audits, oversee the UKAS witness audit process, and develop strong, trusted relationships with regulators, while…
    • Experience with Class III medical device regulatory affairs or equivalent compliance environment.
    • This is an opportunity to register your interest in future…
    • This permanent role offers the flexibility of remote working and will see you play a key part in assessing and improving Quality Management Systems for software…
    • Prior experience supporting medical device submissions or regulatory inspections.
    • Understanding of Class III medical device regulatory requirements and product…
    • Supporting regulatory strategy development and submission planning for Class III medical devices.
    • Maintaining compliance with ISO 13485, IEC 62304 and relevant…
    • Managing regulatory documentation and technical files for medical device submissions.
    • Involvement in supporting the compliance and lifecycle management of Class…
    • Domain: Class III medical device · regulatory affairs.
    • Regulatory expertise is fundamental to bringing medical devices safely to market.
    • Demonstrated experience in medical device regulatory affairs or compliance (medical device or pharmaceutical background).
    • What roles of this type could offer.
    • Access to professional development in medical device regulation and compliance standards.
    • Supporting regulatory strategy and submission planning for Class III…
    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
    • Involvement in bringing innovative medical devices to patients.
    • 3–5 years of regulatory affairs experience within medical device development.
    • Experience supporting Class III medical device development or comparable regulated environments.
    • Involvement in bringing regulated medical devices to market and…
    • Exposure to the full lifecycle of regulated medical device development and compliance.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device…
    • Scope to develop deeper expertise in medical device regulation and compliance frameworks.
    • The opportunity to influence regulatory pathways for medical devices…
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Job Post Details

Internal Auditor - job post

Kiwa
4.0 out of 5 stars
Houghton Hall Park, Dunstable LU5 5ZX
Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Job type

  • Full-time

Shift and schedule

  • Monday to Friday

Location

Houghton Hall Park, Dunstable LU5 5ZX

Benefits

Pulled from the full job description

  • Annual leave
  • Company pension
  • Private medical insurance
  • Cycle to work scheme

Full job description

Job Summary: NQA is seeking an experienced Internal Auditor to join their UK Regulatory team. In this role, you’ll deliver internal audits, oversee the UKAS witness audit process, and develop strong, trusted relationships with regulators, while supporting global compliance and technical excellence. This is a remote role with global responsibility, with some national and international travel. NQA provides accredited certification, training and support services to help customers improve processes, performance and products and services. We have issued over 50,000 certificates to clients in over 90 countries resulting in a yearly revenue of around 100 million Euro. NQA was acquired by Kiwa in 2024, a global leader in the Testing, Inspecting and Certification (TIC) sector, based in the Netherlands. About the role:
  • Deliver internal audits across national and international locations.
  • Manage and respond to external audit findings, including UKAS witness audit outcomes.
  • Coordinate external witness audits, including technical reviews of pre-audit submissions.
  • Provide independent performance evaluation of the operations and field teams to drive continual improvement.
  • Act as a key point of contact for external regulators.
  • Support both internal and external audit activities globally.
  • Provide technical support at UK and international conferences.
  • Produce data and analytical reports for key forums (e.g. Impartiality Committee, Management Review, Directors Strategy meeting).
  • Undertake additional duties within scope, including administrative activities such as complaints, appeals and document control.
Do you have what it takes?:
  • QMS Lead Auditor qualification with a strong background in management systems certification.
  • Strong working knowledge of ISO/IEC 17021 and associated IAF mandatory documents.
  • Knowledge of additional standards (e.g ISO 27006, 17020, 14065, 17065 and 17029) is advantageous.
  • Operational experience in the Testing, Inspection and Certification industry, including regulatory exposure.
  • Broad understanding of accreditation requirements and processes.
  • Excellent planning, organisational and communication skills.
  • Results-driven, with the ability to work independently and achieve set targets.
  • Experience of delivering presentations in business forums (desirable).
  • Willingness to travel nationally and internationally.
What can you expect from us in return?:
  • Competitive Salary - salary details on request
  • 35 hours per week - Monday to Friday, remote role with some national and international travel
  • Generous Annual Leave – Starting at 25 days plus Bank Holidays, increased entitlement with length of service
  • Private Medical Insurance
  • Enhanced Family Leave – Enhanced maternity, adoption, and shared parental leave with 6 months full pay, plus 3 weeks full pay for paternity leave
  • Long service rewards
  • Salary Reviews
  • Enhanced Pension Contributions
  • Life Assurance – 4x your annual salary
  • Cycle Loan Scheme
  • Electric Power Point Loan
  • Free eye tests and contribution towards glasses
  • Welcome Pack – Filled with company-branded goodies to kickstart your journey with us
At Kiwa, we deliver results driven by our core values: Ambitious, Reliable, and Engaged the principles that guide how we work with colleagues, customers, and everyone we encounter. We are committed to fostering personal development, encouraging you to be ambitious, explore new ideas, and contribute to making the world a safer, more sustainable place. Here, you’ll thrive in a dynamic environment with ample opportunities for growth and self-development.
As an equal opportunity employer, Kiwa celebrates diversity and is dedicated to building an inclusive, supportive workplace. We embrace flexibility in hiring talented individuals from all backgrounds globally, ensuring a work environment free from prejudice, discrimination, and intimidation. Inclusivity and equality are core to who we are, and we uphold these values without exception.
If you have any questions about this role and would like to speak a member of the Talent Team, please e-mail us at uk.careers@kiwa.com.
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