FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs for Medical Devices, particularly in Software as a Medical Device (SaMD), with a strong focus on EU MDR and UK MDR compliance, risk management, and technical documentation preparation. Proficient in coordinating with cross-functional teams to ensure compliance and support market access strategies.
Highest-signal resume keywords
Regulatory Affairs ExperienceEU MDR / UK MDR Technical DocumentationRisk Management File OwnershipFDA Submissions ExperiencePMS Plans and Reports
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsTechnical DocumentationRisk ManagementSaMD QualificationIEC 62304IEC 82304-1IEC 62366-1MDCG 2019-11Clinical EvaluationNotified Body Interaction
Soft Skills
Action-OrientedWillingness to LearnOpen to Feedback
Certifications & Qualifications
Disclosure and Barring Service (DBS) Check
Industry Keywords
Medical DevicesSaMDEU MDRUK MDRMHRAFDA 510(k)Market AccessRisk ControlsUsabilityCybersecurity
Tech Stack
Tools & technologiesCyber SecuritySDLC
About the role
Key responsibilities & impact- Prepare, maintain, and update Technical Documentation in line with EU MDR and UK MDR 2002
- Maintain the GSPR checklist and objective evidence from SDLC, cybersecurity, usability, and risk management outputs
- Own labelling and IFU compliance for software, including UDI, eIFU, in-app labelling, and UKCA/CE marking requirements
- Support software qualification, classification rationale, and intended purpose statements
- Support clinical evaluation for software
- Assess software releases and design changes for regulatory impact, including significant change determination and notified body notification
- Own and maintain the SaMD risk management file, including hazard analysis, risk controls, and benefit-risk determination
- Ensure risk outputs are traceable to software requirements, verification, usability, and Technical Documentation
- Support PMS plans, PMS reports/PSURs, and PMCF plans and evaluation reports
- Analyse complaints, incidents, trends, and real-world performance data
- Support vigilance reporting to MHRA and EU competent authorities, including FSCAs and trend reporting
- Coordinate with Engineering, Clinical, and Quality teams on corrective actions and submissions
- Support UKCA and CE marking and MHRA registrations
- Support international market access, including FDA 510(k)/De Novo and other markets
- Monitor SaMD and AI/ML regulatory intelligence and assess impact on products and the QMS
- Support CAPA and internal audit follow-ups where regulatory root causes are identified
Requirements
What you’ll need- 3 to 6 years' Regulatory Affairs experience in Medical Devices, with a focus on SaMD
- Proven experience preparing and maintaining EU MDR / UK MDR Technical Documentation for software for notified body review
- Hands-on experience owning a risk management file for SaMD under ISO 14971
- Practical application of MDCG 2019-11 / EU MDR Rule 11 for SaMD qualification and classification
- Experience with IEC 62304, IEC 82304-1, and IEC 62366-1
- Hands-on notified body interaction responding to NCs or review questions
- FDA submissions experience for software devices preferred
- Experience with PMS plans, PSURs, and PMCF plans and reports
- Must complete a Disclosure and Barring Service (DBS) check
- Action-oriented approach and willingness to learn and grow through open feedback
Benefits
Comp & perks- 25 days annual leave + up to 8 UK bank holidays
- Option to buy or sell holidays
- Flexible remote options
- Remote working stipend
- Employee stock options
- 4% pension on full basic pay
- 4x salary life insurance
- Private health insurance
- 4 months full pay for birthing parent
- 4 weeks full pay for non-birthing parent
- Phased return back to paid work
- Sick pay
- Free daily lunch
- Pet-friendly office
- £500 L&D budget per person
- Cycle to work scheme
- 24/7 GP appointments
- Mental health support
- Nutrition & fitness advice
- Second opinions & health checks
- Competitive compensation package including base and stock options
- Half-year and annual performance reviews
- Opportunities for growth and leadership