Medical Technology Jobs

162 jobs for “regulatory affairs”

Results

Johnson & Johnson MedTech logo

Johnson & Johnson MedTech · 10000+ people · Public

Senior Analyst, Regulatory Program Management – Immunology

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  • Allschwil, Switzerland
  • Hybrid
  • Senior

Operational leader driving regulatory program management for the Immunology portfolio, translating global regulatory strategy into executable plans and coordinating cross-functional teams. Facilitates health authority meeting planning, worldwide submissions and marketing applications while leading change management for new processes and systems across the RPM team.

Veeva · Microsoft Project · Planisware

5 days ago
Johnson & Johnson MedTech logo

Johnson & Johnson MedTech · 10000+ people · Public

Senior Analyst, Regulatory Program Management – Immunology

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  • Beerse, Belgium
  • Hybrid
  • €74,000 – €117,530 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 health authority meeting planning, worldwide submissions and marketing applications, while leading change management and process improvements across the RPM department.

Veeva · Microsoft Project · Planisware

5 days ago

GE HealthCare

Medical Monitor

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  • United Kingdom, YY9 9YY
  • Remote
  • Mid-level

Provides day-to-day medical oversight for one or more clinical trials, ensuring patient safety, data integrity and protocol compliance. Reviews and assesses AEs and SAEs, supports safety signal detection with Pharmacovigilance, and advises investigators on eligibility and dosing. Works cross-functionally with Clinical Operations, Data Management, Biostatistics and Regulatory Affairs, and contributes to CSRs and regulatory submissions.

Data Safety Monitoring Boards

Last month

SRG

Quality Engineer

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  • Lancashire
  • On-site
  • Mid-level
  • Contract

Maintains and improves a medical device Quality Management System in line with ISO 13485 and FDA QSR, leading non-conformance, deviation, complaint and CAPA investigations with root cause analysis. Supports internal, supplier and regulatory audits, risk management under ISO 14971, validation and design transfer, working with Manufacturing, R&D, Regulatory Affairs and Supply Chain.

3 weeks ago

Jazz Pharmaceuticals

Senior Principal Statistician, Biostatistics

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  • Cambridge
  • Remote
  • Lead

Lead statistician responsible for the statistical design, analysis and reporting of Phase I–IV clinical trials and regulatory filings, including writing and reviewing statistical analysis plans and validating CRO deliverables. Works cross-functionally with clinical development, regulatory affairs and medical writing, using SAS and R, with CDISC standards and Bayesian/adaptive design experience preferred.

SAS · R

Last week

Jazz Pharmaceuticals

Senior Principal Statistician, Biostatistics

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  • London
  • Remote
  • Lead

Lead statistician responsible for the statistical design, analysis and reporting of Phase I–IV clinical trials and regulatory filings, including writing and reviewing statistical analysis plans and validating CRO deliverables. Works cross-functionally with clinical development, regulatory affairs and medical writing, using SAS and R, with CDISC standards and Bayesian or adaptive designs preferred.

SAS · R

Last week

OrganOx · 11–50 people · Series B

Programme Manager (R&D)

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  • Oxford
  • On-site
  • Mid-level
  • Permanent

Accountable for end-to-end delivery of strategic New Product Development programmes, leading multidisciplinary teams across R&D, regulatory, quality, operations and commercial functions. Drives integrated programme plans, stage-gate governance, risk management, resource planning and budget forecasting for complex medical device development in a regulated environment, supporting the metra® organ perfusion platform.

FDA Quality System · Design History Files

Last week

OrganOx · 11–50 people · Series B

Software Quality Engineer

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  • Oxford
  • On-site
  • Mid-level
  • Permanent

Assures software quality across the full lifecycle for medical devices up to IEC 62304 safety class C, covering design controls, requirements, verification and validation, and release management. A central duty is software risk management, developing and maintaining SFMEAs, hazard analyses and cybersecurity risk assessments aligned with ISO 14971. Works with R&D, Engineering, Post-Market Operations, Regulatory Affairs and Cybersecurity to support EU MDR and FDA compliance.

IEC 62304 · ISO 14971 · ISO 13485 +5

6 days ago
Newton Colmore logo

Newton Colmore · 11–50 people

Medical Devices Consultant - Senior Mechanical Engineer

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  • Cambridge
  • Senior
  • Permanent

Medical Devices Consultant - Senior Mechanical Engineer - CambridgeDue to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role.…

15 months ago

Medtronic · 10000+ people · Public

Principal Medical Science Liaison

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  • London
  • Remote
  • £77,040 – £115,560 pa
  • Lead

Serves as a senior scientific expert for the Neuromodulation & Pelvic Health portfolio, leading external scientific engagement with KOLs, healthcare professionals and medical societies across Western Europe. Delivers evidence-based clinical information, runs advisory boards, CME programmes and congress activities, and partners with clinical, regulatory and commercial teams on medical affairs strategy. Remote UK-based role with frequent travel.

2 months ago
ECM Selection logo

ECM Selection

Medical Device Programme Lead

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  • Cambridge
  • £75,000 – £95,000 pa
  • Lead

Lead high-value medical device development programmes from concept through to transfer to manufacture, with a focus on drug delivery systems such as injectables, infusion pumps, microcatheters and active implants. The role combines hands-on mechanical and systems engineering oversight with strategic and commercial direction, mentoring colleagues and identifying business opportunities. Requires international travel to meet clients, investors and manufacturing partners.

2 weeks ago

GE HealthCare

Biomedical Engineer- London Site Based

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  • London
  • On-site
  • Mid-level

Provide on-site maintenance, repair and management of medical devices across hospital sites, ensuring equipment reliability and regulatory compliance. Work with team leaders and account managers on contractual KPIs, maintain CMMS service records, manage spare parts inventory and travel to other healthcare sites as needed.

Microsoft Office · CMMS

4 days ago

Hudson Shribman

Preclinical In-Vitro Toxicology Scientist

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  • United Kingdom
  • £55,000 – £70,000 pa

This role involves leading and executing in-vitro toxicology studies, including Neutral Red, Ames, and micronucleus assays, within a regulated laboratory environment. The scientist will develop and optimise testing methodologies, interpret complex biological data, and support regulatory submissions. They will work collaboratively across multidisciplinary teams and with external partners to advance pre-clinical testing capabilities in product safety assessment.

3 weeks ago

Robert Walters

Compliance Director

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  • Edinburgh
  • On-site
  • Director
  • Permanent

This role involves leading and developing a global compliance framework, providing expert guidance on anti-bribery, GDPR, export controls, and ethics. You will ensure alignment with global regulatory and quality standards, oversee whistleblowing processes, and drive compliance risk assessments. The position offers the opportunity to shape compliance strategy in a regulated, innovation-led sector.

6 days ago

Hyper Recruitment Solutions

Product Compliance Officer

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  • Hertfordshire

Own product regulatory compliance end to end, acting as the company's official representative and evidencing compliance to external parties. Advise on sourcing, development, composition, packaging, labelling and marketing, horizon-scan regulatory changes, and support domestic and European product registrations plus safety data sheet software. Requires REACH/CLP knowledge and a chemical or QA background.

MS Office · Word · Outlook +2

3 weeks ago

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