Medical Device QA/RA Associate (Regulatory Submissions & QMS Documentation Support)

Overview I’m looking for a Medical Device QA/RA Associate to support me with regulatory and quality deliverables for one or more ongoing projects. You will work directly with a senior QA/RA consultant and help with both regulatory strategy/submissions and QMS documentation. This role is ideal for someone who has hands-on experience with medical device regulatory and quality activities and wants to deepen their experience by working closely with a more senior RA/QA lead. Key Responsibilities Regulatory (RA) Support -Assist in developing regulatory strategies for medical devices (e.g., US, EU, and other markets as applicable). -Support preparation of regulatory submissions, which may include: -US FDA submissions (e.g., 510(k), Pre-Subs) -EU MDR technical documentation support (e.g., for NB review) -Other market registrations as needed Draft and/or refine regulatory documents such as: -Device descriptions, indications for use -Substantial equivalence / clinical evaluation justifications -Risk/benefit summaries and labeling content -Conduct targeted regulatory research (guidances, standards, NB/FDA expectations) and summarize findings in a clear, actionable format. Quality (QA) & QMS Documentation -Draft, edit, and maintain QMS procedures, SOPs, work instructions, forms, and records, primarily for medical devices (e.g., ISO 13485 / FDA QSR-aligned systems). -Help structure and organize documentation for: Document control -Design control / DHF -Risk management (ISO 14971) -CAPA, complaints, and other post-market processes (as needed) -Prepare or update templates for recurring activities (logs, checklists, forms, etc.). Collaboration & Communication -Join regular status calls (video/voice) to review tasks, clarify expectations, and align on priorities. -Communicate proactively via Upwork messages and shared tools (e.g., Google Workspace, Office 365, or similar). -Be responsive to feedback and iterate on drafts quickly and accurately. Training & Learning -Complete onboarding/training on project-specific processes, templates, and tools. Be open to training and mentoring on regulatory strategy, submission structure, and QMS best practices. Follow provided guidance and examples to ensure alignment with project style, level of detail, and expectations. Required Qualifications -Experience in Medical Device QA/RA – typically at least 2+ years in a medical device environment (manufacturer, consultant, or similar). Working knowledge of at least one of the following: -FDA regulations and guidance for medical devices (e.g., 21 CFR Part 807, Part 820, 510(k) basics). -EU MDR framework and expectations (e.g., technical documentation, GSPRs, post-market requirements). Hands-on experience drafting and/or maintaining: -SOPs, work instructions, forms, and quality records -Documentation aligned with ISO 13485 and basic risk management (ISO 14971) -Strong written English and ability to produce clear, structured, and concise documents. -High attention to detail, especially for consistency, traceability, and version control. Nice-to-Have (Preferred) -Direct experience supporting or drafting FDA 510(k) submissions or sections thereof. -Exposure to EU MDR technical documentation (e.g., Annex II / III) or NB interactions. Experience with: -Design control / DHF documentation -Risk files (FMEA, hazard analysis) -Clinical / performance evaluation inputs (at least at a basic level) -Familiarity with common QMS e-systems or document control tools. Soft Skills & Working Style -Organized and structured – able to keep track of multiple documents and tasks. -Comfortable working with checklists and templates, and following established structures. -Proactive communicator – asks clarifying questions when needed, but also proposes solutions. -Willing to accept iterative feedback and improve drafts quickly. -Reliable availability for scheduled calls (we will agree on time zones and typical windows). Apply tot his job