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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…
    • Improve device efficiency, stability, and manufacturability.
    • Enable affordable, scalable next-generation materials and devices.
    • Experience in medical device design or other highly regulated industries is desirable.
    • You will play a key role in new product introduction (NPI), working cross…
    • Experience within medical devices or another highly regulated industry.
    • Ensure compliance with medical device design control and regulatory standards.
  • View similar jobs with this employer
    • This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
  • View similar jobs with this employer
    • 5+ years of relevant experience in the medical device space (either industry or through consulting/service provider).
    • The Product Manager, Life Sciences & OEM Partnerships reports to the VP & GM - Advanced Assays and Centre for Excellence, & is accountable for driving…
    • Improve device efficiency, stability, and manufacturability.
    • Enable affordable, scalable next-generation materials and devices.
  • View similar jobs with this employer
    • Experience in a regulated industry, preferably within medical devices or healthcare technology.
    • Lead complaint investigations and perform root cause analysis to…
    • 3–5 years' experience in Product Management or Marketing within the medical device industry.
    • Medical device sales, healthcare solutions or clinical consulting…
    • Design, develop and maintain software for our upcoming medical device, owning features from concept through release.
    • Identify and ensure compliance with ISO13485 and ISO9001standards, and regulations related to IVD medical devices products.
    • Job Types: Full-time, Permanent.
    • £45,000 - £50,000 + Training + Early Finish Friday + Enhanced Pension + Life Assurance + Hybrid Opportunities.
    • Ensure compliance with medical device regulations, standards, and internal gated processes.
    • Minimum 5 years' experience in a technical engineering role within…
    • Verification & validation testing of medical devices.
    • Experience in electronic design within medical devices or regulated industries.

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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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