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    • This pivotal role involves overseeing regulatory compliance, ensuring that medical device products meet all necessary standards and regulations.
    • Proven experience in Scientific or Medical Affairs within the medical device industry, ideally with a focus on surgical devices.
    • Ownership and creation of key design history file documentation.
    • The creation of marketing claims and supporting evidence summaries.
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    • Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite…
    • The role is suited to a capable engineer who has already worked through structured product development processes and is ready to take ownership of design…
    • Good knowledge and understanding of medical devices and their regulatory requirements.
    • The position requires a strong understanding of medical device regulatory…
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    • Experience in a regulated industry, preferably within medical devices or healthcare technology.
    • Lead complaint investigations and perform root cause analysis to…
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    • You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain…
    • Providing expert GVP and PV legislation guidance across the organisation, and ensuring that regulatory changes translate into timely, concrete action.
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    • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
    • Co-ordinate, lead and develop the team of internationally based regulatory consultants engaged in global notification services (ca. 10 - 15 staff).
    • Experience producing medical device risk analysis.
    • Support device classification and regulatory strategy activities.
    • Hours: *Full time, 37.5 hours per week.
    • Experience of audits in pharma or devices arena preferable.
    • Comprehensive Healthcare – Company contributed private medical insurance for your well-being.
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    • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
    • Identify and ensure compliance with ISO13485 and ISO9001standards, and regulations related to IVD medical devices products.
    • Job Types: Full-time, Permanent.

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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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