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, reputed company. We don’t reputed company MedTech. We reputed company MedTech happen. Our reputed company teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on reputed company. 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 reputed company our client's medical device operations. This individual will assist with CAPA management, vendor reputed company, documentation control, and other compliance-reputed company 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-reputed company field OR equivalent experience in regulatory or quality roles reputed company 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 reputed company 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. reputed company 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 reputed company of our job applicants. To ensure a safe application process: reputed company 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 Apply To this Job Apply tot his job Apply To this Job