Job Description
Key Responsibilities
QMS Assessment & Implementation Support
Conduct gap analyses of current QMS processes against ISO 13485, 21 CFR Part 820, and EU MDR requirements under the guidance of Senior BAs and QA leadership
Support documentation of QMS processes, SOPs, work instructions, forms, and quality records across design, manufacturing, and post-market phases
Experience
8+ years of experience in Business Analysis, Quality Assurance, or Regulatory Affairs within the medical device industry
Minimum 5 years of direct involvement in QMS implementation, documentation, or compliance activities for regulated medical devices
Experience working on Class II or Class III medical device programs in FDA and/or EU regulatory environments
Exposure to SaMD (Software as a Medical Device) or connected device programs is advantageous
Technical Standards Knowledge
ISO 13485 2016 — Working knowledge; experience applying requirements across QMS processes
21 CFR Part 820 — Familiar with FDA QSR structure, design controls, and DHF expectations
EU MDR 2017/745 — Basic to intermediate understanding; experience contributing to Technical Files
IEC 62304 — Exposure to software lifecycle documentation and classification
IEC 82304-1 — Awareness of health software requirements
IEC 62366-1 — Familiarity with usability engineering deliverables
ISO 14971 2019 / ISO 24971 2020 — Understanding of risk management processes and documentation
Certifications (Preferred)
CCBA or CBAP (Certification in Business Analysis / Certified Business Analysis Professional)
RAPS RAC (Regulatory Affairs Certification)
ISO 13485 Internal Auditor or Lead Auditor
ASQ CQPA or CQE (Quality Process Analyst / Quality Engineer)
