Regulatory Affairs / Quality Assurance Associate/Specialist
RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better. We don’t make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency Remote | Temporary Position, 40 hours/week for 3+ months We are seeking a detail-oriented and motivated RA/QA professional to support key regulatory and quality activities within our client's medical device operations. This individual will assist with CAPA management, vendor oversight, documentation control, and other compliance-related tasks. While experience with Software as a Medical Device (SaMD) is a plus, it is not required Key Responsibilities:
- Support the execution and documentation of Corrective and Preventive Actions (CAPAs)
- Assist in vendor qualification, monitoring, and management activities
- Maintain and update quality and regulatory documentation (procedures, work instructions, forms, etc.)
- Help prepare regulatory submissions and responses under supervision
- Participate in internal audits and support external audit readiness
- Track and follow up on quality metrics and improvement initiatives
- Collaborate cross-functionally with RA, QA, Operations, and Engineering teams Qualifications
- Bachelor’s degree in a scientific, engineering, or healthcare-related field OR equivalent experience in regulatory or quality roles within the medical device industry
- 1–3 years of experience in RA/QA for medical devices (SaMD experience is a plus but not required)
- Familiarity with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory frameworks
- Strong organizational and communication skills
- Proficiency with document control systems and bolthires Office tools Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity Verification At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview. Exercise caution with unsolicited job offers or requests for sensitive information. Apply tot his job Apply tot his job
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