Remote | Medical Device Quality & Regulatory Workflow Specialist -- $60-$85/hour
5 days ago
New York
Job Description We are sharing a specialised part-time consulting opportunity for professionals experienced in medical devices, regulatory affairs, quality engineering, design controls, manufacturing validation, supplier quality, clinical affairs, and structured regulated-device documentation. This role supports current and upcoming remote consulting opportunities focused on structured medical device workflow review, regulatory documentation, quality system assessment, design history file review, validation documentation, CAPA analysis, and high-quality project execution. Selected professionals will apply their medical device expertise to review realistic regulated-device scenarios, evaluate technical and compliance requirements, prepare structured written outputs, and support accurate, evidence-based medical device workflow tasks. Key Responsibilities Professionals in this role may contribute to: Regulatory Affairs & Submission Documentation • Review medical device scenarios involving 510(k), PMA, De Novo, EU MDR, technical files, regulatory submissions, and supporting documentation, • Evaluate regulatory materials against source records, device requirements, submission expectations, and documented review criteria, • Support structured review of regulatory correspondence, submission packages, technical documentation, and device classification materials, • Review quality scenarios involving DHF, DMR, risk-analysis matrices, CAPA records, eQMS workflows, validation protocols, and quality documentation, • Evaluate materials against 21 CFR 820, ISO 13485, ISO 14971, design control requirements, risk management expectations, and quality system procedures, • Support structured review of CAPA documentation, risk files, quality records, post-market surveillance materials, and MDR/vigilance reporting workflows, • Review device R&D and manufacturing scenarios involving design controls, software-related device workflows, process validation, supplier quality, and manufacturing engineering documentation, • Evaluate validation protocols, supplier records, manufacturing workflows, and device development materials against defined technical requirements, • Support structured review of materials connected to ANSYS Fluent, STAR-CCM+, Siemens Opcenter, Rockwell FactoryTalk, DocuSign, eQMS systems, or similar regulated-device tools Strong candidates may have: • 3+ years of experience in medical devices, regulatory affairs, quality engineering, design controls, R&D, manufacturing engineering, process validation, supplier quality, clinical affairs, post-market surveillance, or related regulated-device roles, • Experience in one or more areas such as 510(k), PMA, De Novo, EU MDR, technical files, 21 CFR 820, ISO 13485, ISO 14971, CAPA, DHF, DMR, SaMD, process validation, supplier quality, or vigilance reporting, • Familiarity with tools and systems such as ANSYS Fluent, STAR-CCM+, Siemens Opcenter, Rockwell FactoryTalk, DocuSign, eQMS platforms, PLM systems, MES platforms, or similar medical device workflow tools, • Comfort reading and preparing medical device artifacts such as design history files, regulatory submissions, DHF/DMR documents, risk-analysis matrices, validation protocols, CAPA records, supplier files, and technical summaries, • Strong analytical thinking and written communication skills, • A degree or professional background in biomedical engineering, mechanical engineering, electrical engineering, regulatory affairs, quality engineering, life sciences, clinical research, manufacturing engineering, or a related field is helpful, • Experience at a medical device manufacturer, contract developer, contract manufacturer, healthcare technology company, or regulated life sciences organization, • Familiarity with design controls, risk management, FDA submissions, EU MDR, SaMD, eQMS, supplier quality, process validation, CAPA, clinical affairs, or post-market surveillance, • Experience preparing or reviewing regulatory submissions, technical files, validation protocols, DHF/DMR materials, CAPA records, risk files, or quality documentation, • RAC, ASQ CQE, CRE, CBA, regulatory affairs, quality, validation, or medical device certifications are helpful, • Apply medical device regulatory, quality, and engineering expertise to structured remote project work, • Contribute to high-quality device documentation review, regulatory workflow assessment, quality system analysis, and validation scenario development, • Work on flexible, project-based assignments aligned with your medical device background, • Use your regulated-device judgment in a focused, detail-oriented review environment, • Independent contractor role, • Fully remote with flexible scheduling, • Part-time commitment depending on project availability, • Competitive rates between $60–$85 per hour depending on expertise, • Weekly payments via Stripe or Wise, • Projects may be extended, shortened, or adjusted depending on scope and performance This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams. By submitting this application, you acknowledge that your information may be processed by 24-MAG LLC for recruitment and opportunity matching in accordance with our Privacy Policy: .
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