Medical Technology Jobs

137 jobs for “Regulatory Affairs Manager”

Results

Johnson & Johnson MedTech logo

Johnson & Johnson MedTech · 10000+ people · Public

Manager Medical Affairs International (m/f/d)

  • Machelen, Belgium
  • €93,500 – €149,845 pa
  • Mid-level

Field-based Medical Affairs role supporting Shockwave Medical's cardiovascular portfolio across Europe. Involves building KOL relationships, managing investigator-initiated studies, providing scientific and HEOR support, reviewing promotional materials, and representing the company at conferences. Requires close cross-functional work with Clinical, Regulatory, Marketing and Market Access teams.

Microsoft Office · Word · Excel +3

2 months ago
Johnson & Johnson MedTech logo

Johnson & Johnson MedTech · 10000+ people · Public

Manager, Medical Writing, Immunology

  • Toronto, Canada
  • US$134,000 – US$184,000 pa
  • Mid-level · manages people

Leads preparation and finalisation of clinical documents within the Regulatory Medical Writing team, supporting the Immunology therapeutic area. Takes a lead role on assigned programmes, planning and directing writing groups, mentoring junior writers and overseeing external contractors. Also manages direct reports, setting objectives and running performance and development discussions.

2 weeks ago
Newton Colmore logo

Newton Colmore · 11–50 people

Regulatory Affairs Engineer - Medical Devices

  • 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

2 weeks ago

Smith & Nephew · 1001–5000 people · Public

Senior Specialist - Clinical Study Management

  • UK - Field
  • Hybrid
  • Senior

Leads complex, S+N-sponsored clinical studies from start-up to close-out, acting as project leader within cross-functional teams spanning biostatistics, data management, regulatory affairs and vendors. Develops protocols, monitoring plans and consents, oversees vendors and site management, manages study budgets, and ensures GCP and ISO 14155 compliance. Also trains junior clinical study management staff.

ISO 14155 · ISO 9001 · ICH-GCP

2 days ago

Medstrom

Quality and Regulatory Coordinator

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

Support the Director of Quality Assurance & Regulatory Affairs in maintaining and improving the Quality Management System, coordinating change requests, customer investigations, root cause analysis and audit documentation. Maintain Post Market Surveillance records and work across departments to ensure products and processes meet regulatory requirements. Based at Head Office in Castle Donington, working 37.5 hours per week.

Last week

QIAGEN

Senior Director Medical Affairs, Oncology Precision Diagnostics

  • 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

SRG

Quality Engineer

  • 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.

Last month

Appcast Enterprise

Head of Global Labelling

  • 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.

5 days ago

Reed Specialist Recruitment

Packaging Engineer

  • Gloucestershire
  • £58,000 – £63,000 pa
  • Senior

Owns packaging and labelling validation for a global medical device portfolio, leading transportation testing, shelf-life studies and equipment validation projects. Reviews technical documentation, BOMs and labelling content, leads CAPAs and non-conformance investigations, and acts as key contact during regulatory audits. Works cross-functionally with Quality, Regulatory, R&D and Manufacturing, mentoring junior staff.

ASTM

2 weeks ago

B. Braun Medical Ltd

Goods In & Dispatch Coordinator

  • Sheffield
  • On-site
  • Permanent

Receiving and inspecting medical devices against technical drawings, then labelling, packaging and preparing goods for dispatch. Booking couriers, tracking parcels, supporting the stores and warehouse, and logging customer quality complaints for Regulatory Affairs. Combines hands-on goods handling with SAP-based administration in a busy Technical Services team.

SAP

4 days ago

Medtronic · 10000+ people · Public

Principal Medical Science Liaison

  • 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.

3 months ago

L-ev8 Recruitment Ltd

Senior Quality & Regulatory Affairs Specialist

  • 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.

3 weeks ago
Newton Colmore logo

Newton Colmore · 11–50 people

Mechanical Engineer - Genomics Instrumentation

  • Cambridge
  • Mid-level

Design and develop mechanical components for genomics instrumentation, working within a multidisciplinary team of physicists, electronics engineers, software developers and life sciences specialists. The role spans the full product lifecycle from concept and prototyping through to design for manufacture and launch, ideally within medical devices, diagnostics or scientific instrumentation and regulated environments such as ISO 13485 and FDA QSR.

2 weeks ago
ECM Selection logo

ECM Selection

Medical Device Programme Lead

  • 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.

3 weeks ago

GE HealthCare

Biomedical Engineer- London Site Based

  • 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

Last week

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