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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 product management or product development.
    • Understanding of product lifecycle management and how they influence product decisions.
    • 3–5 years' experience in Product Management or Marketing within the medical device industry.
    • Support product launches and develop compelling value propositions.
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    • Experience in product management, product ownership or a closely related role.
    • Gathering and synthesising customer feedback to inform product decisions.
    • Act as product owner for services in cross-functional and international group environments.
    • The core of this role is translating complex, often bespoke…
    • Enjoys building products, not just managing tickets.
    • Understanding of modern digital product delivery and continuous improvement practices.
    • Ownership and creation of key design history file documentation.
    • The creation of marketing claims and supporting evidence summaries.
    • Partner with product management and R&D to align on product strategy/roadmap.
    • Vitalograph is the world’s leading manufacturer of medical respiratory diagnostic…
    • If you like being the person who makes complicated things happen on time, this one's for you.
    • You'll be the glue between formulation scientists, regulatory…
    • Experience creating and managing technical product documentation, specifications, technical files and product data.
    • 25 days annual leave plus Bank Holidays.
    • Partner with product management and R&D to align on product strategy/roadmap.
    • Vitalograph is the world’s leading manufacturer of medical respiratory diagnostic…
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    • Strong understanding of product development, commercialization pathways, and lifecycle value creation.
    • Commercial Assessments: Lead the development of global…
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    • Managing regulatory submissions and dossier preparation for medical devices or pharmaceuticals.
    • In-depth knowledge of ISO 13485, IEC 62304 and Class III medical…
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    • Ensuring product compliance with ISO 13485, IEC 62304 and relevant medical device regulations.
    • Potential to develop specialist expertise in medical device…
    • Monitoring product performance and driving continuous improvement.
    • Experience managing product roadmaps and lifecycle delivery.

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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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