Medical Technology Jobs

162 jobs for “regulatory affairs”

Results

Bluetree logo

Bluetree · 11–50 people

Senior Regulatory Affairs & Quality Manager

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  • Cambridge
  • Hybrid · 2 days in office
  • £65,000 – £80,000 pa
  • Senior
  • Permanent

Lead regulatory strategy for a cardiology device company expanding into the US, UK, EU and Middle East, owning FDA, CE and UKCA submissions from Class I to Class II/III. Drive an audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971) and advise senior leadership on regulation, quality and clinical governance, working directly with the FDA, MHRA and notified bodies.

FDA · MHRA · UKCA +2

Featured 2 weeks ago
Newton Colmore logo

Newton Colmore · 11–50 people

Regulatory Affairs Specialist - Medical Devices - Cambridge

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  • Cambridge
  • Mid-level

Provide regulatory support across a Cambridge product development business, guiding multidisciplinary engineering and science teams on compliance with ISO 9001, ISO 13485 and FDA 21 CFR 820. Monitor international regulatory changes, support external audits and contribute to quality management system improvements across medical and non-medical projects.

2 weeks ago
Newton Colmore logo

Newton Colmore · 11–50 people

Regulatory Affairs Engineer - Medical Devices

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  • Cambridge

Hands-on regulatory support across multiple engineering projects, working alongside design engineers and scientists to embed compliance into product development. Applies ISO 9001, ISO 13485 and FDA 21 CFR 820 to interpret requirements, manage design controls and track international regulatory changes. Also supports QMS improvement and external audit preparation.

ISO 9001 · ISO 13485 · FDA 21 CFR 820

Last week

Sustainable Infrastructure

Regulatory Affairs Manager

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  • Bristol
  • Hybrid · 2 days in office
  • £55,000 – £75,000 pa
  • Mid-level
  • Permanent

Lead regulatory submissions for Software as a Medical Device products, owning documentation, defining UK, EU and US pathways, and coordinating evidence across software, clinical and quality teams. You'll handle FDA 510(k)/De Novo work, manage regulator and Notified Body interactions, and assess product changes for lifecycle compliance in a small, fast-moving medtech business.

FDA · Notified Bodies

Last week

Healthium Clinics

Regulatory Affairs Associate / Compliance Officer

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  • Henley-on-Thames
  • £32,000 – £38,000 pa
  • Mid-level
  • Permanent

Support regulatory affairs and compliance across healthcare, digital health and medical-device activity. Maintain the Quality Management System, medical-device technical documentation, risk registers and audit actions, while coordinating evidence for tenders, CQC inspections and information governance. Acts as a link between clinical, technical and commercial teams.

ISO 13485 · ISO 14971 · IEC 62304 +7

3 weeks ago
Johnson & Johnson MedTech logo

Johnson & Johnson MedTech · 10000+ people · Public

Oncology Global Regulatory Affairs Intern (EMEA)

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  • High Wycombe
  • Hybrid · 3 days in office
  • Entry level
  • Internship

A 12-week summer internship in EMEA Global Regulatory Affairs within the Oncology therapeutic area, supporting the development of oncologic therapeutics across Phase I to III clinical studies. The intern joins a global matrixed team, contributes to cross-functional trial team activities, and conducts a research project on a topic impacting the regulatory function, presenting findings at a company-wide research symposium.

Microsoft Outlook · Microsoft Excel · Microsoft PowerPoint +5

4 days ago

Get new regulatory affairs roles by email. One email a morning when new roles match. Stop any time.

L-ev8 Recruitment Ltd

Senior Quality & Regulatory Affairs Specialist

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  • Burgess Hill
  • £50,000 pa
  • Senior
  • Part time

Part-time role maintaining quality and regulatory compliance for a Class I(s) medical device manufactured by an approved contract manufacturer. You will oversee supplier quality, review batch documentation, validation and change control, maintain technical files, and support audits, vigilance and post-market surveillance, working closely with the Head of Quality and sharing PRRC responsibilities.

2 weeks ago

GPW Recruitment

Quality & Regulatory Engineer

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  • Houghton le Spring
  • On-site
  • Temporary

Support quality assurance, product compliance and regulatory activities in a medical device manufacturing environment. Maintain quality control systems, prepare technical documentation, conduct testing and inspections, investigate non-conformances using CAPA, analyse quality data and support internal and external audits, working closely with the QA Manager and production teams.

ISO 13485 · EU MDR

2 weeks ago

QIAGEN

Senior Director Medical Affairs, Oncology Precision Diagnostics

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  • Manchester
  • Hybrid
  • Director · manages people

Lead the global Medical Affairs strategy for an oncology precision diagnostics portfolio, shaping biomarker and companion diagnostic initiatives with pharma and biotech partners across the drug development lifecycle. Engage key opinion leaders and cross-functional teams in a matrixed international environment, representing the company at conferences and advisory boards.

QIAGEN

Last month

Medstrom

Quality and Regulatory Coordinator

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  • Derby
  • On-site
  • £35,000 – £45,000 pa

Supports the Quality Management System for a medical device and healthcare services provider, coordinating change requests, customer investigations, root cause analysis and audit documentation. Maintains Post Market Surveillance records and works closely with the Director of Quality Assurance & Regulatory Affairs at the Castle Donington head office.

3 days ago

Kes Solutions

Quality and Regulatory Engineer

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  • Houghton le Spring
  • On-site
  • Mid-level
  • Temporary

Support the design, manufacture, testing and regulatory compliance of medical devices, maintaining quality control systems, production protocols and documentation. Investigate non-conformances and complaints, run CAPA, testing and validation, and assist with EU MDR, ISO 13485 and audit readiness, including clean room operations.

2 weeks ago
Johnson & Johnson MedTech logo

Johnson & Johnson MedTech · 10000+ people · Public

Senior Analyst, Regulatory Program Management – Immunology

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  • Leiden, Netherlands
  • Hybrid
  • €64,500 – €104,535 pa
  • Senior

Operational leader driving regulatory program management for the Immunology portfolio, translating global regulatory strategy into executable plans and coordinating cross-functional teams. Facilitates Global Regulatory Team meetings, leads submissions and health authority meeting planning, and champions process and system rollouts within the RPM department.

Veeva · Microsoft Project · Planisware

5 days ago

Appcast Enterprise

Head of Global Labelling

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  • Maidenhead
  • Director · manages people

Leads the global labelling function for an influenza vaccine portfolio, owning the end-to-end review and approval process and setting labelling strategy across regions. Chairs the Global Labelling Committee, sits on the regulatory leadership team, and manages time-critical annual strain updates while representing the company in external regulatory forums.

Today

Adecco · 10000+ people · Public

Study Manager

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  • Welwyn Garden City
  • £377 – £500 ph
  • Mid-level
  • Contract

Coordinate early-phase clinical trials within a pharmaceutical Clinical Operations team, covering study start-up, feasibility, timelines, recruitment and vendor oversight. Maintain TMF documentation, risk logs and regulatory compliance under ICH-GCP while working with Data Management, Regulatory Affairs and external partners.

Trial Master Files · Microsoft Office

3 weeks ago

Office Angels

Quality Administrator

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  • Stirling
  • On-site
  • £26,436 pa
  • Entry level

A varied Quality Assurance and Regulatory Affairs role in a regulated warehouse environment, maintaining compliance documentation, supporting product licence applications, and reviewing labels and packaging. You'll carry out quality checks, assist with investigations, CAPAs, deviations and change controls, and maintain training records and controlled documents alongside warehouse, production and commercial teams.

Microsoft Word · Microsoft Excel

2 days ago

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