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Medical device safety manager

Unity Systems
Hertfordshire
1 week ago
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Job Title:Medical Devices Clinical Safety Team Member

Contract Duration:12 months (15/09/2025 – 14/09/2026)

Start Date:15/09/2025

Location:Office-based, hybrid considered

Right to Work:Full UK RTW required (no sponsorship)

Overview:

We are seeking a highly experienced Medical Devices Clinical Safety professional to join a global life sciences organization. The ideal candidate will bring deep expertise in medical device (MD) and/or in-vitro diagnostic (IVD) safety within the pharmaceutical, biotech, or medical device industry.

Key Responsibilities:

  • Contribute as a core member of the Medical Devices Clinical Safety Team
  • Act as subject matter expert on MD/IVD safety and regulatory compliance
  • Lead or support development and implementation of MD safety processes
  • Provide consultation to safety teams and internal stakeholders
  • Participate in safety reviews, audits, CAPAs, and expert group forums
  • Contribute to training and mentoring of colleagues in MD safety
  • Stay current on industry standards, trends, and regulatory changes

Requirements:

  • University degree (preferably in life sciences) or equivalent professional experience
  • Extensive experience in MD or IVD safety
  • Familiarity with global MD safety regulations and standards
  • Strong knowledge of pharmacovigilance and clinical safety integration
  • Proven ability to work cross-functionally and influence stakeholders
  • Excellent communication, leadership, and collaboration skills

Preferred:

  • Experience with combination products or due diligence evaluations
  • Involvement in expert safety groups or training initiatives


Medical device safety, clinical safety, in-vitro diagnostics, IVD, pharmacovigilance, combination products, medical device regulations, risk management, CAPA, audit support, clinical safety specialist, medical device clinical safety lead, process improvement, safety signal detection, regulatory compliance, cross-functional collaboration, safety governance, SOP development, WI development, global safety standards, due diligence, safety team member, medical device expert, ISO 13485, FDA 21 CFR Part 820, GxP compliance, device vigilance, safety training, stakeholder engagement, technical documentation, lifecycle safety management, clinical investigations, safety risk assessment, hybrid working, life sciences, biotech, safety strategy, audit readiness, safety data analysis, global safety processes

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