Remote | Medical Device Quality & Regulatory Workflow Specialist
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
- Identify missing information, documentation gaps, regulatory inconsistencies, and expected submission review outcomes
Quality Systems, Risk & CAPA Review
- 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
- Prepare clear written explanations for quality and regulatory decisions based on source materials and verifiable criteria
Design Controls, Manufacturing & Validation Support
- 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
- Maintain accuracy, consistency, and professional judgment across submitted work
Ideal Profile 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
- Ability to translate regulated medical device workflows into clear, structured task documentation
Educational Background
- 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
- Equivalent practical experience in medical device regulatory, quality, R&D, manufacturing, clinical affairs, or validation workflows is also highly relevant
Nice to Have
- 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