Senior MDR Specialist

We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where posting has real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate. Must preserve all substantive info. We need to parse the posting. Key sections: - About the role: maybe the "General Summary" paragraph. - Responsibilities: "Duties And Essential Functions" list. - Requirements: maybe "Qualifications" includes Preferred Education, Preferred Experience. - Skills: maybe "Technical Knowledge" and "Soft Skills". - Benefits: none mentioned? Not in posting. So omit Benefits, Pay, Schedule. - Pay: none. - Schedule: maybe "FULL-TIME/PART-TIME: Full Time" but that's schedule info. The instruction: include a section ONLY when posting has real, specific content. It has "Full Time". That's schedule. So we could include a Schedule section with that info. However they said "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state Full Time. So we can include Schedule section with that. - Benefits: none. - Pay: none. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Schedule. But note they said "Prefer a few substantive sections over many thin ones." Could combine Qualifications and Requirements? But they list separate headings allowed. We'll follow. We need to use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We must not repeat job title as heading. So no heading for Senior MDR Specialist. We need to preserve all substantive info. Let's extract. About the role: The "General Summary" paragraph: "The Senior MDR Specialist is responsible for overseeing the end-to-end medical device complaint handling process, ensuring compliance with global post-market surveillance and vigilance requirements. This role manages a team responsible for complaint intake, investigation oversight, eMDR submissions to the U.S. FDA and Medical Device Problem Reporting to Health Canada. The Senior MDR Specialist partners closely with Quality, Regulatory Affairs, Service/Technical Support, Engineering, and Original Equipment Manufacturers (OEMs)/Suppliers to ensure timely identification, assessment, investigation, and escalation of product quality and safety issues while driving continuous improvement initiatives." We'll put that in

  . Responsibilities: The "Duties And Essential Functions" list includes bullet points. We'll extract each bullet as

• . The text: - Supervise daily operations of the MDR complaint handling team. - Ensure complaint records are accurately documented, investigated, and closed within established timelines. - Conduct Quality Check (QC) Reviews for complaint record completeness, quality, and regulatory compliance. - Conduct the review and submission of Medical Device Reports (MDRs). - Ensure timely determination of reportability in accordance with 21 CFR Part 803. - Maintain reporting metrics and ensure compliance with global vigilance requirements. - CAPAs arising from complaint investigations, adverse events, audits, inspections, and trend analyses. - Support root cause investigations utilizing tools such as 5 Whys, Fishbone Diagrams, and Failure Analysis. - Support internal and external audits, including FDA, Notified Body, and ISO 13485 audits. - Coach and mentor MDR complaint handling personnel. - Drive a culture of compliance, accountability, collaboration, and continuous improvement. - Develop and monitor KPIs related to MDR compliance. - Identify opportunities to streamline complaint handling and reporting processes. - Lead quality improvement initiatives that enhance efficiency and compliance. We need to ensure we keep all. Also there is "Technical Knowledge" and "Soft Skills" maybe under Skills. Requirements: maybe "Preferred Education" and "Preferred Experience". We'll treat as Requirements. Qualifications: maybe they want separate Qualifications section? The posting has "Qualifications Preferred Education" and "Preferred Experience". Could treat as Qualifications. But we already have Requirements. Might combine? The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have both Requirements and Qualifications. But we need to avoid duplication. Let's assign: - Requirements: maybe the mandatory requirements? The posting only has "Preferred Education" and "Preferred Experience". Those are preferences, not strict requirements. Could treat as Qualifications. But we need to decide. Better: Use Requirements for the "Preferred Education" and "Preferred Experience". Use Qualifications for maybe "Demonstrated experience with FDA reporting and Health Canada Medical Device Problem Reporting. Experience working within an ISO 13485 and FDA-regulated environment." Actually those are also under Qualifications? The posting lists under "Qualifications" heading: "Preferred Education ... Preferred Experience ..." then after that there is a list of items: "Demonstrated experience with FDA reporting and Health Canada Medical Device Problem Reporting. Experience working within an ISO 13485 and FDA-regulated environment." Those are also qualifications. Thus we can have Qualifications section containing those bullet points. Skills: Technical Knowledge and Soft Skills. Let's extract Technical Knowledge list: - FDA 21 CFR Part 803 (Medical Device Reporting) - FDA Quality System Regulations and/or Quality Management System Regulation (QMSR) - ISO 13485 - ISO 14971 Risk Management - SOR/98-282 Health Canada Medical Device Regulations - EU Medical Device Regulation (MDR) and post-market surveillance requirements preferred - Complaint handling databases and electronic quality management systems (eQMS), experience with TrackWise Digital preferred Soft Skills: - Critical Thinking & Accountability: Makes sound, risk-based decisions, takes ownership of compliance and team performance, and drives issues to timely resolution. - Collaboration & Relationship Management: Builds productive relationships with cross-functional teams, suppliers, and OEMs to resolve complex quality and regulatory challenges. We'll put each as
• under Skills. Schedule: "FULL-TIME/PART-TIME: Full Time". We'll put in

  maybe. Now we need to output HTML fragment only. Structure:

  About the role

  ...

  Responsibilities

  • ...
  ...

  Requirements

  Preferred Education: Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, Quality, Regulatory Affairs, or a related scientific field.

  Preferred Experience: 5+ years of experience in medical device complaint handling, vigilance, post-market surveillance, or quality systems. 2+ years of leadership or supervisory experience preferred.

  Alternatively could use
  for each but it's prose. We'll use

  .

  Qualifications

  • Demonstrated experience with FDA reporting and Health Canada Medical Device Problem Reporting.
  • Experience working within an ISO 13485 and FDA-regulated environment.

  Skills

  • FDA 21 CFR Part 803 (Medical Device Reporting)
  • FDA Quality System Regulations and/or Quality Management System Regulation (QMSR)
  • ISO 13485
  • ISO 14971 Risk Management
  • SOR/98-282 Health Canada Medical Device Regulations
  • EU Medical Device Regulation (MDR) and post-market surveillance requirements preferred
  • Complaint handling databases and electronic quality management systems (eQMS), experience with TrackWise Digital preferred
  • Critical Thinking & Accountability: Makes sound, risk-based decisions, takes ownership of compliance and team performance, and drives issues to timely resolution.
  • Collaboration & Relationship Management: Builds productive relationships with cross-functional teams, suppliers, and OEMs to resolve complex quality and regulatory challenges.

  Schedule

  Full Time

  Check we didn't miss any substantive info: The "Physical Demands" and "Working Conditions" maybe could be included? They are substantive but not under allowed headings. Could we include them under a section like "Working Conditions"? Not in allowed list. The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings but says "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are the allowed headings. So we should not add other headings. Should we drop Physical Demands and Working Conditions? They are substantive but not fitting allowed headings. The instruction: "Prefer a few substantive sections over many thin ones." It might be okay to omit those details if they don't fit headings. However they said "Preserve ALL substantive information; do NOT invent or summarize away detail." That's a conflict. We need to preserve all substantive info. If we cannot add a heading for Physical Demands, maybe we can incorporate them into existing sections like Responsibilities or Skills? But they are not really responsibilities. Could add a paragraph under Responsibilities? Might be okay to add a

  under Responsibilities about physical demands? But that would be mixing. Better to create a section like "Working Conditions" but not allowed. However the instruction says "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests examples, not exhaustive list. So we could add other headings if needed, as long as we use

  . The important part is to not repeat job title, not put Job ID, etc. So we could add a section for "Working Conditions". But they said "Prefer a few substantive sections over many thin ones." Adding a section for Physical Demands might be thin. Could combine Physical Demands and Working Conditions into a section like "Work Environment". That's substantive. Let's add a section "Work Environment" with Physical Demands and Working Conditions. But we need to check if they'd consider that okay. The instruction: "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid others. So we can add. We'll add

  Work Environment

  with

  containing both Physical Demands and Working Conditions sentences. Let's extract Physical Demands: "Requires normal visual acuity and hearing. Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives. Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard. Additional skills may be required to perform additional task(s) specific to work location, department or line of business." Working Conditions: "Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment. Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care." We'll combine. Now we must ensure we didn't miss any other substantive info: The "React Health is a fast-paced..." description at start maybe belongs to About the role? Already we have General Summary. Could also include that description as part of About the role. The "General Summary" is after that description. The initial paragraph about React Health is also substantive. Should we include it? It describes the company. Could be part of About the role. We'll add that to About the role paragraph as well. Thus About the role will have two paragraphs: first about React Health, second the General Summary. Or combine into one

  with both sentences. Let's craft: