Independent Contractor – Clinical Trials Quality & Compliance Manager
Cardiovascular Associates of America - CVAUSA
Google Cloud Platform
Regulatory Affairs – Design Control Specialist
Radformation
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $140,000 - $170,000 per year
Job Level
Mid-LevelSenior
About the role
- Establish project-specific technical file deliverable lists aligning with internal SOPs, FDA QMSR, and EU MDR.
- Utilize appropriate templates for each deliverable, including but not limited to requirements, usability, risk, clinical evaluation, and verification and validation.
- Leverage existing content where applicable.
- Coordinate deliverables across teams, ensuring owners understand expectations, receive guidance, and that progress is tracked appropriately within eQMS and ALM systems.
- Present project deliverables during inspections and internal/external audits.
- Analyze performance data and internal processes to identify improvement opportunities.
- Assist and support JIRA–ALM integration.
- Consult with Product and Development teams to interpret regulatory intent and maintain compliance with evolving design control and technical file expectations.
- Assist with international regulatory submissions and applications.
- Perform other quality and regulatory-related duties as assigned (e.g., validation of quality and regulatory applications).
Requirements
- 5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience.
- 3+ years in a project management or technical leadership role.
- Experience working in a regulated agile development environment.
- Familiarity with global medical device regulations: QSR/QMSR, MDD/CMDR/MDR.
- Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards.
Benefits
- Multiple high-quality medical plan options with premiums covered for employees (with subsidized coverage for dependents).
- Health coverage starting on day one.
- Short-term and long-term disability and supplementary life insurance.
- 401(k) with employer match vested immediately.
- Annual reimbursement for professional memberships.
- Conference attendance and continued learning opportunities.
- Self-managed PTO and 10 paid holidays.
- Monthly internet stipend and one-time home office setup stipend.
- Fully remote work environment with virtual events and yearly retreats.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementtechnical leadershipquality systemsregulatory submissionsrisk analysisclinical evaluationverification and validationagile developmentISO 13485ISO 14971
Soft skills
communicationcoordinationguidanceanalytical thinkingteam collaboration
