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    • 3+ years in the medical device industry in a similar Regulatory role.
    • This pivotal role involves overseeing regulatory compliance, ensuring that medical device…
    • Within this, we are looking to grow our healthcare and life science practice with highly motivated and collaborative individuals who will bring an understanding…
    • Supporting client delivery: contributing to strategic planning and consultancy services.
    • Team contribution and development: supporting project teams and…
    • In conjunction with the Director and other colleagues you will help achieve the overall business plan to grow and develop strategic healthcare planning as a…
    • This fellowship is hosted in memory of our friend and colleague Andrew Nixon and will be focused on the completion of a service improvement project within our…
    • Managing the implementation and delivery of a range of risk services to designated project(s) within the PMO and Planning centre of excellence.
    • Commitment to maintaining high standards of medical ethics and patient care.
    • The successful candidate will be responsible for performing minor surgical and…
    • Understanding of medical device cybersecurity standards.
    • Ensure all service activities comply with UK medical device regulations and company procedures.
    • The role will include holding consultations with patients around their hair loss and creating their hair transplant surgical plan.
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    • Private Healthcare Scheme for treatment at our hospitals, covering pre-existing medical conditions.
    • This is a full-time role for 37.5 hours a week.
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    • Review medical reports and lab results.
    • Attend ethics committee meetings as necessary.
    • Review medical records of potential study participants.
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    • Conduct informed consent discussions and medical assessments.
    • Support medical governance and regulatory compliance activities.
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    • Conduct informed consent discussions and medical assessments.
    • Support medical governance and regulatory compliance activities.
  • View similar jobs with this employer
    • Conduct informed consent discussions and medical assessments.
    • Support medical governance and regulatory compliance activities.
  • View similar jobs with this employer
    • Review medical reports and lab results.
    • Attend ethics committee meetings as necessary.
    • Review medical records of potential study participants.

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Job Post Details

Senior Regulatory Professional - Medical Devices - job post

MCA Recruitment recruiting on behalf of our client
London
£55,000 - £58,000 a year - Permanent, Full-time

Job details

Pay

  • £55,000 - £58,000 a year

Job type

  • Permanent
  • Full-time

Shift and schedule

  • Monday to Friday

Location

London

Benefits

Pulled from the full job description

  • Sick pay
  • Company pension
  • Private medical insurance
  • Health & wellbeing programme
  • Company events
  • Transport links
  • On-site parking

Full job description

Job Summary

We are seeking an experienced Senior Regulatory Professional specialising in Medical Devices to join our clients dynamic team. This pivotal role involves overseeing regulatory compliance, ensuring that medical device products meet all necessary standards and regulations. The ideal candidate will possess a strong background in quality assurance and have a comprehensive understanding of medical device regulations across various markets. This position offers an excellent opportunity to contribute to innovative healthcare solutions within a collaborative and forward-thinking organisation.

Located in North London. Excellent transport links.

The hours 8.30am to 5pm, or you can do 8am to 4.30pm.Monday to Friday.

The Package

  • Salary £55,000 to £57,000 dependent on experience
  • Bonus
  • 25 days Holiday plus bank holidays
  • The company will support you with professional development, this is very important to them.
  • Private Healthcare
  • Online GP Services -Access to an online GP service

Experience

3+ years in the medical device industry in a similar Regulatory role.

  • Strong knowledge of EU MDR 2017/745, ISO 13485, and other relevant international regulatory frameworks and standards.
  • Proven ability to compile, maintain, and submit Technical Documentation, product registrations, and regulatory submissions to authorities and Notified Bodies.
  • Experienced in clinical evaluation activities, including Clinical Evaluation Plans/Reports, literature reviews, and post-market clinical follow-up.
  • Solid understanding of labelling compliance, product classification, intended use determination, and regulatory pathways during product development.
  • Skilled in post-market surveillance and vigilance activities, including adverse event reporting, PSURs, and field safety corrective actions.
  • Able to monitor, interpret and communicate regulatory changes to the business in language that is easy to understand.
  • Strong, pragmatic collaborator across Quality, Clinical, Marketing, R&D, and Operations, supporting product launches and ongoing compliance.
  • Familiarity with QMS processes and regulatory audits/Notified Body inspections, with exposure to sterile manufacturing environments considered a plus.

This role is ideal for professionals committed to advancing healthcare through rigorous regulatory oversight and quality assurance excellence.

Pay: £55,000.00-£58,000.00 per year

Benefits:

  • Company events
  • Company pension
  • Health & wellbeing programme
  • On-site parking
  • Private medical insurance
  • Sick pay

Application question(s):

  • Is your current location commutable to North London on a daily basis ?

Experience:

  • MDR 2017/745, ISO 13485 directives : 3 years (required)
  • submit Tech Docs, product regs, and regulatory submissions : 3 years (required)

Work authorisation:

  • United Kingdom (required)

Work Location: In person

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