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Jobs/Regulatory Affairs Specialist Role/scarlet - Regulatory Education Specialist (Quality)
scarlet

scarlet - Regulatory Education Specialist (Quality)

Remote - UK£60k - £80k2w ago
RemoteMidEMEAMedical DevicesEducationRegulatory Affairs SpecialistFounderRegulatory ComplianceSAP

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Requirements

• You have 3+ years of experience supporting Quality Management System (QMS) implementation, audit preparation, or regulatory compliance activities under EU MDR, UK MDR, MDSAP, and/or ISO 13485. • You understand what makes a high-quality QMS and what it takes to prepare companies for audits. • You have experience teaching, designing training, or working with Learning Management Systems.

Responsibilities

• Create high-quality content that enables medical device innovators to understand the QMS and audit requirements of EU MDR, UK MDR, MDSAP, 510(k), ISO 13485 and others. • Design education-grade materials, including slides, diagrams, lesson plans, and voiceover scripts, for use across videos, knowledge base articles, and enablement tools. • Lead structured dialogues that clarify core concepts, surface common pitfalls, and align medical device innovators on what “good” looks like. • Work closely with the auditors to ensure that everything we publish reflects a consistent, aligned regulatory view. • THE INTERVIEW PROCESS • Intro call with Aarzoo https://www.linkedin.com/in/aarzoosidhu/ • Round 1: Team interviews: Interview with Steven https://www.linkedin.com/in/steven-byrne-4a958434/ and Johan http://linkedin.com/in/johan-julin/?skipRedirect=true (2x30 min) • Round 2: Founder interviews: Interview with James https://www.linkedin.com/in/james-dewar-78758992/ and Jamie https://www.linkedin.com/in/jamie-cox-01458b3a/ (2x30 min)

Benefits

• £60K – £80K • Offers Equity • Where are you currently based? • Please provide a link to your LinkedIn Profile

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