Overview
Remote
On Site
Full Time
Skills
Regulatory Compliance
Change Management
Medical Devices
QMS
ISO 13485
Application Lifecycle Management
Jama
Product Development
Quality Assurance
Research and Development
Organizational Skills
Management
Documentation
Technical Writing
Collaboration
Communication
Job Details
Responsibilities:
- Draft, update, and optimize QMS procedures to align with Codebeamer upgrades, organizational standards, and regulatory requirements.
- Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations.
- Translate technical and regulatory requirements into clear, practical documentation for end users.
- Support change management processes, ensuring procedural updates are properly controlled and communicated.
- Ensure documentation is compliant with ISO 13485, 21 CFR Part 820, EU MDR, and internal quality system standards.
- Partner with stakeholders to validate that documentation aligns with both product development processes and regulatory needs.
- Requirements:
- Proven experience in the medical device industry, with strong knowledge of QMS documentation and procedures.
- Hands-on experience authoring and revising procedures compliant with ISO 13485, 21 CFR Part 820, and EU MDR.
- Familiarity with Codebeamer or similar ALM systems (e.g., Polarion, Jama, etc.).
- Strong understanding of regulatory and product development processes across Quality Assurance and R&D.
- Excellent technical writing, documentation, and organizational skills.
- bility to work independently, manage multiple priorities, and deliver within tight project timelines.
- Preferred Qualifications:
- Prior experience supporting system upgrades or documentation alignment projects.
- Background in technical writing within regulated environments.
- Strong collaboration and communication skills, with the ability to partner across functions.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.