RQM+

QA Engineer

• 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

Regulatory Affairs – Quality Assurance Associate/Specialist

Auditor

• Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
• Providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
• Identifying and supporting the development of training modules required by the Audit Practice.
• Maintaining their training in new / revised regulations, standards and guidance's as they become available.
• This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
• As an auditor there will be challenging situations and difficult conversation with the client. The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right.

Lead Auditor, ISO 13485

ISO 13485 Lead Auditor

• Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
• Providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
• Identifying and supporting the development of training modules required by the Audit Practice.
• Maintaining their training in new / revised regulations, standards and guidance's as they become available.
• This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
• As an auditor there will be challenging situations and difficult conversation with the client.

• Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
• Providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
• Responsible for identifying opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back to the RQM+ business development team.
• Supporting the training and development of junior auditors, providing them with guidance and support.
• Identifying and supporting the development of training modules required by the Audit Practice.
• Maintaining their training in new / revised regulations, standards and guidances as they become available.
• This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
• As an auditor there will be challenging situations and difficult conversations with the client. The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right.

Clinical Practice Auditor

Data Scientist

• Assist the Clinical Data Science Lead with setup activities including eCRF development, edit check specification review, and DMP/eCCG documentation preparation.
• Participate in User Acceptance Testing (UAT) of the Electronic Data Capture (EDC) system by executing test scripts, tracking results, and ensuring issues are entered into the UAT issues logs.
• Ensure completeness and timely filing of startup documentation in the Trial Master File (TMF).
• Responsible for query generation/resolution for data operations throughout the study conduct phase.
• Perform ongoing review of Data Management listings to identify missing, inconsistent, or out-of-range data; escalate issues to the Clinical Data Science Lead as appropriate.
• Support review of reconciliation listings (e.g., central labs) to ensure accuracy and completeness of cross-system data and assist in reconciliation specification development.
• Generate and distribute regular status reports and help track query aging and resolution rates.
• Maintain agendas and meeting minutes for internal and external meetings involving data operations.
• Track document completion timelines to ensure adherence to study milestones and TMF readiness.
• File and QC study documentation in the Trial Master File (TMF), ensuring compliance with ICH-GCP and SOPs; ensure studies are ‘audit-ready’.
• Perform periodic TMF reviews related to Data Management documents to identify gaps or outdated files and update TMF accordingly.
• Support coding of events/histories/medications using MedDRA and WHO DD licenses.
• Support data entry needs and development of project-specific procedures as required.
• Support user access review to ensure appropriate EDC access and assist the Clinical Data Manager with database locking.
• Responsible for data archival at the end of the trial in support of the Project Management team.

Clinical Data Science Associate

Compliance

• Develop and maintain Regulatory Strategies to release and maintain product in accordance with the Standards and Regulatory requirements
• Interface with regulatory agencies such as FDA and Notified Bodies (NB)
• Provide RA leadership/support to New Product Development (NPD) teams
• Provide strategic direction on labeling, regulations, and standards
• Support the regulatory aspects of medical devices and/or diagnostic devices across a range of classifications
• Collaborate cross-functionally with R&D, manufacturing, medical, clinical, non-clinical and marketing to incorporate their reports into submissions
• Create, edit, review, and maintain regulatory submissions to support country specific marketing approval (Technical Documentation, Design Dossiers, 510(k), IDE, PMA, de novo, etc.)
• Submit and/or review PMAs/supplements/30-day notices
• Obtain approvals for new medical devices, and/or SW and/or diagnostics and determine regulatory impact of design/process changes
• Maintain product registration and review changes and registration updates as required to either regulators or NBs
• Develop, maintain, review, product labels, Instructions for Use (IFU) and any associated marketing material for compliance with applicable regulations and technical standards
• Participate in strategy development for reimbursement
• Perform gap assessments and propose remediation for regulatory submissions including technical files to EU MDR and/or IVDR
• Support International Registration Requests and coordinate device change communication to regulatory agencies across the globe as necessary
• Participate in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions
• Provide acquisition due diligence and integration
• Review and provide input on clinical trials required for strategy development
• Compile/contribute to Investigational New Drug Applications (IND) and New Drug Applications (NDA)

Regulatory Affairs Consultant

• The Technology & Analytics Lead supports the Technical Program Management (TPM) function and collaborates with all Laboratory groups to ensure smooth execution of programs and commercial initiatives. This role focuses on tracking targets, analyzing performance, and facilitating communication across departments to drive operational efficiency and business growth. Working closely with Lab Services leadership, Business Development, Sales, and Finance, the Coordinator plays a key role in monitoring project performance, identifying process improvements, and providing the data and insights needed to support strategic decision-making.

Technology and Analytics Lead

Director

• RQM+ is The MedTech CRO delivering regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies.
• We are seeking an experienced and strategic Director of Toxicology to lead our Toxicology team and deliver high-quality scientific services to clients.
• Responsible for overall performance, development, and direction of the Toxicology function with emphasis on operational excellence, client satisfaction, financial performance, and team leadership.
• Provide expert scientific and regulatory guidance on toxicology-related matters; review and approve toxicology protocols, reports, and client deliverables.
• Stay current on developments in toxicology, regulatory expectations, and emerging methodologies; provide strategic guidance on toxicology, risk assessment, and client engagement strategies.
• Lead initiatives to enhance team performance, process consistency, quality assurance, and continuous improvement; define and track KPIs.
• Collaborate with finance and leadership on budgets, resource allocation, pricing strategies, and monitor financial performance to meet revenue and margin goals.
• Serve as key client contact on toxicology projects; cultivate strong client relationships and support business development and proposal efforts.
• Lead, mentor, and develop the Toxicology team; oversee resource planning, workload balancing, performance management, talent acquisition, onboarding, and training.

Director of Toxicology

• 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
• The Clinical Data Manager (CDM) is responsible for day-to-day data management operations for RQM+ and its clients; collaborates with the Manager of Clinical Data Operations to provide a proactive approach to data validation from initial set up, through maintenance and into locking / archiving the EDC database.