Sam Bacon
Regulatory Affairs Specialist - Medical Devices @Sgb Qa Ra Consulting Ltd
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WORK HISTORY
Regulatory Affairs Specialist - Medical Devices @Sgb Qa Ra Consulting Ltd
Bristol, GB
Designed and implemented QMS and ISMS frameworks, ensuring compliance with ISO 13485:2016, ISO 27001:2013, and supporting audits, certification, and remediation for Class I–IIb devices and SaMD.Prepared and managed Technical File Summary Reports under UK MDR 2002 (UKCA) and EU MDR 2017/745 (CE Mark), including STED-formatted risk management, GSPR, and essential requirements evaluations.Led FDA regulatory submissions (Traditional 510(k), 513(g), Enforcement Discretion), MDSAP projects, post-market surveillance (PMS), and clinical evaluation reports (CERs) to enable global market access.Managed EU/UK market access and compliance programs, including device classification, labelling/artwork (ISO 15223:2021), UDI/EUDAMED registration, EU Authorised Representative, UK Responsible Person, and NHS DTAC/DSPT/DCB0129 initiatives.Conducted GAP analyses, audits, and remediation activities, providing ISO 13485-certified internal auditing, Notified Body report remediation, and ensuring sustained compliance with international regulatory standards.
EDUCATION
London Metropolitan University
BA Hons Marketing and Economics, Marketing
Clevedon School, Clevedon, North Somerset
10 GCSEs - Grades A - C
SKILLS
ABOUT SAM BACON
I am a Medical Device Regulatory Consultant and Software as a Medical Device (SaMD) specialist with extensive experience supporting startups and SMEs across the UK, EU, and US. I help medical device companies navigate complex regulatory environments, implement robust quality systems, and achieve market access efficiently and confidently.Key Expertise Includes:• Quality Management Systems (QMS): Design, implementation, and remediation to ISO 13485:2016, supporting regulatory compliance and audit readiness.• Regulatory Submissions & Technical Documentation: Production of Technical File Summary Reports for UK MDR 2002 (UKCA) and EU MDR 2017/745 (CE Mark); management of FDA submissions including 510(k) for US market access.• Information Security & Certification: Development and implementation of ISO 27001-compliant ISMS, successfully supporting certification for digital health and SaMD products.• Risk Management & Post-Market Compliance: ISO 14971-based risk files, PMS, CERs, device classification, labelling, and UDI/EUDAMED registration.• Advisory & Strategic Support: Trusted advisor for startups and SMEs, including my role as Entrepreneur in Residence (EiR) at SETsquared Bristol, guiding early-stage companies on regulatory strategy, compliance, and growth.I bring a pragmatic, results-driven approach to every project, helping companies not only meet compliance standards but also accelerate product development, market entry, and long-term business success.If you are a MedTech founder, startup, or SME seeking expert guidance in regulatory strategy, SaMD compliance, or market access, I’d be happy to connect.
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