Sr MDR Specialist

Masimo•Irvine, CA

20h•$86,000 - $108,000•Onsite

About The Position

The Senior MDR Specialist is responsible for leading and supporting Medical Device Reporting (MDR), vigilance, and adverse event reporting activities to ensure compliance with applicable domestic and international regulatory requirements. This role serves as a subject matter expert (SME) within the Quality and Regulatory organization for complaint evaluation, reportability assessments, regulatory submissions, and post-market surveillance activities. The Sr. MDR Specialist partners cross-functionally with Regulatory Affairs, Clinical, Quality, Engineering, and Manufacturing teams to ensure timely and accurate adverse event reporting, support audit readiness, identify compliance risks, and drive continuous improvement initiatives related to complaint handling and global vigilance processes.

Requirements

Strong knowledge of Medical Device Reporting (MDR), vigilance systems, adverse event reporting, and complaint handling processes within a regulated medical device environment.
Extensive working knowledge of FDA regulations including 21 CFR Part 803, 21 CFR Part 820, and applicable global vigilance reporting requirements.
Strong understanding of EU MDR vigilance requirements, ISO 13485, and post-market surveillance regulations.
Experience performing MDR reportability assessments and preparing/submitting regulatory reports to health authorities.
Experience reviewing complaint investigations, root cause analyses, and product evaluation documentation to support regulatory reporting decisions.
Strong understanding of regulatory reporting timelines, escalation requirements, and documentation standards.
Ability to interpret and apply complex regulatory requirements and make sound risk-based compliance decisions.
Strong analytical, critical thinking, and problem-solving skills with high attention to detail.
Excellent written and verbal communication skills with strong technical writing and documentation capabilities.
Ability to manage multiple priorities and work effectively in a fast-paced, highly regulated environment.
Strong collaboration skills and ability to work cross-functionally with internal stakeholders and regulatory teams.
Proficiency in Microsoft Office, electronic quality management systems (eQMS), complaint handling databases, and regulatory reporting tools.
Experience preparing and submitting Manufacturer Incident Reports (MIRs) and supporting EU MDR vigilance reporting requirements.
Experience responding to regulatory authority inquiries, deficiency requests, and follow-up communications related to adverse event reporting and vigilance activities.
Strong understanding of global regulatory reporting requirements, including FDA MDR and EU MDR vigilance processes.
Demonstrated technical writing skills with the ability to prepare clear, accurate, and compliant regulatory responses and submissions.
Ability to read, write, and communicate effectively in English.
Ability to interpret technical documents, schematics, and written instructions.
Ability to clearly document technical findings and communicate with cross-functional team members.

Nice To Haves

Experience in medical device, diagnostics, biotechnology, or other FDA-regulated industries.
Experience with global vigilance reporting requirements including EU, Canada, Australia, and other international markets.
Experience supporting FDA inspections, notified body audits, or international regulatory audits.
Familiarity with risk management processes, CAPA systems, and post-market surveillance programs.
Experience mentoring or training team members on MDR and complaint handling processes.
Experience with electronic MDR (eMDR) submissions and regulatory reporting systems.
Knowledge of MedWatch, EUDAMED, and other global regulatory reporting platforms.
Experience driving process improvement initiatives related to complaint handling, vigilance, or regulatory compliance workflows.
Experience interacting directly with regulatory agencies, notified bodies, or competent authorities regarding MDR, MIR, vigilance, or post-market surveillance activities.
Familiarity with EUDAMED vigilance reporting processes and global adverse event reporting systems.

Responsibilities

Lead and manage Medical Device Reporting (MDR), vigilance, and adverse event reporting activities in accordance with FDA, EU MDR, and other applicable global regulatory requirements.
Review, assess, and process complaint records to determine reportability, regulatory impact, investigation requirements, and escalation needs.
Perform timely and accurate MDR submissions, adverse event reports, vigilance reports, and supplemental/follow-up reports to applicable regulatory authorities.
Ensure compliance with regulatory reporting timelines and maintain complete, accurate, and audit-ready documentation for all reportable events.
Conduct reportability assessments in accordance with 21 CFR Part 803, EU MDR vigilance requirements, and applicable international regulations.
Collaborate cross-functionally with Regulatory Affairs, Clinical, Engineering, Manufacturing, and Quality teams to support complaint investigations and obtain required information for regulatory reporting activities.
Review complaint investigations, product evaluations, and root cause analyses to ensure appropriate regulatory reporting decisions are made.
Monitor complaint data, adverse event trends, and post-market surveillance activities to identify recurring issues, emerging risks, or potential safety concerns requiring escalation.
Support Health Hazard Evaluations (HHEs), field actions, recalls, and regulatory communications as applicable.
Maintain and support global vigilance and complaint handling procedures, workflows, and quality system documentation.
Support internal audits, external inspections, and regulatory agency inquiries related to MDR and vigilance activities.
Provide guidance and mentorship to junior team members regarding complaint evaluation, MDR decision-making, and regulatory reporting requirements.
Participate and own CAPA activities, risk assessments, and continuous improvement initiatives related to complaint handling and post-market surveillance processes.
Monitor departmental metrics and reporting performance indicators to ensure compliance with internal objectives and regulatory expectations.
Maintain strong working knowledge of applicable regulations, guidance documents, and industry best practices related to MDR and vigilance reporting.
Respond to regulatory authority inquiries, requests for additional information, and follow-up communications related to MDRs, vigilance reports, adverse events, field actions, and post-market surveillance activities.
Prepare, review, and submit Manufacturer Incident Reports (MIRs) in accordance with EU MDR vigilance requirements and applicable international regulatory standards.
Coordinate cross-functional efforts to gather, evaluate, and provide accurate technical, clinical, and investigational information in response to regulatory agency requests and report follow-up activities.
Support regulatory inspections and audits by providing MDR, MIR, vigilance, and complaint handling documentation and serving as a subject matter expert during regulatory interactions.