RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

As a complaint handler consultant, you will support the complaint investigation process and execution for product design and process related complaints for Post-Market Medical Device and Combination Products.

Responsibilities:

Develop S1 / S2 (low risk) complaint rationale based on reported severity and documented severity in the risk file.

Review any determined S1 / S2 (low risk) severity product quality complaints and S1 / S2 (low risk) adverse events report, evaluate investigation requirements and close with rationale or indicate additional activities.

Required to review any “no” reportable decisions (non-serious complaints) on a weekly basis to ensure appropriate rationale and conclusion.

Reportable and not-reportable decisions to be documented in complaints database.

Supports establishment of complaint handling policies and procedures.

Coordinate activities to generate health hazard assessment in collaboration with medical affairs/safety.

Collaborate with site Quality to ensure issues within scope follow NTM process for proper product containment decisions.

Escalate any new, unknown device risk or hazards, or any event with reported severity greater than the documented severity in the hazard analysis (HA) to Safety for evaluation and assessment.

Coordinate/investigate device complaints in accordance with 21 CFR Part 820.198 and directs events to the appropriate investigating sites (manufacturing site, distribution, design center, safety, and regulatory).

Determine if an investigation is required and by who for the complaints reviewed.

Review device/combination product complaints investigations.

Review root cause determination of the reported events and assesses any shift in patient risk from reported complaints against the documented risk profile.

Review production, design, use, failure analysis for reported events and related investigations.

Review and evaluate complaints for MDR decisions in accordance with 21 CFR Part 803.

Review users/patients and clinical/safety information for MDR determination.

Coordinate with complaint investigation team to determine if the reported complaint was associated with a malfunction, serious injury or death and whether the complaint documentation is complete and accurate.

Document final reportability of complaints per MDR regulations in accordance with 21 CFR Part 803 and other applicable global regulatory agency requirements.

Ensure submission of complaints requiring an MDR to the FDA and other applicable global regulatory agency requirements and ensure supplemental MDR submitted of the new or added information.

Ensure complete and accurate reporting of complaints as required by applicable regulatory agencies, standards and guidelines.

Ensure high level of quality and consistency in event decision evaluation and reportability of complaints.

Requirements:

Minimum Education: Certified RN or PA

5- 15 years of complaints and MDR experience

Technical Experience: Therapeutic Area/Device Class/Geographies

Customer focused with excellent communication skills (written and verbal)

Focused on the direct support of our customers by providing expert technical solutions for device and device constituent related issues using telecommunication, chat or other emerging technologies.

Recognizes the clinical significance of the products and its use.

Displays a sense of urgency to resolve customer issues.

Communicates with empathy and respect to customers, peers and business partners

Identifies root cause to issues reported by customers and provides appropriate solutions

Supports Continuous Quality Improvement as well as customer satisfaction goals through modeling of appropriate ethical behavior in the work environment conducive to attaining goals

Able to clearly explain and present technical information within and outside of the organization (i.e. technical resource to 3rd Party vendors, medical personnel, marketing, service publications, training, R&D, etc.)

Being an industry leader in client support is just the beginning for RQM+.  Providing a rewarding place to work is rooted deep in the core values of RQM+.  From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment.  At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today! We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us. We require willingness to work a flexible schedule and travel at least 25% of the time 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.

We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us.

We require willingness to work a flexible schedule and travel at least 25% of the time

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.

Clinician Complaint Handler Consultant

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