Senior Complaint Specialist
Anika
August 20, 2026
Remote friendly (Bedford, MA)
United States
$84,000 - $110,000 USD yearly
Patient Advocacy
Senior Complaint Specialist – Role Responsibilities
- Manage end-to-end lifecycle of global customer complaints across multiple sites (intake, assessment, investigation, resolution, closure) with compliant MDR handling.
- Evaluate complaints for Medical Device Reporting (MDR) requirements; determine reporting obligations per FDA/ISO/EU MDR.
- Conduct root cause analyses, lead investigations, and write high-quality investigation reports.
- Use complaint management systems to document, track, trend, and report quality/complaint metrics.
- Monitor complaint trends; escalate potential quality/safety signals.
- Support Post Market Surveillance data collection, trending, and regulatory reporting inputs.
- Collaborate with clinical sites, physicians, hospitals, sales, and suppliers to gather complaint information.
- Support CAPA and Change Control (investigation support, documentation, effectiveness verification).
- Apply risk management principles (ISO 14971) and align with design/process controls.
- Maintain compliant complaint files (GDP); serve as trainer/SME; support audits and continuous improvement.
Qualifications / Required
- Bachelor’s in Engineering/Life Sciences or related, or equivalent experience.
- 3+ years complaint handling and quality systems documentation.
- Knowledge of FDA 21 CFR Part 820 and 21 CFR Part 211; ISO 13485; EU MDR 2017/745; global regulatory requirements.
- Experience with investigations/root cause analysis/documentation; CAPA/Change Control support.
- Risk/design control familiarity (ISO 14971).
- Analytical/problem-solving skills; interpret technical/quality data.
- Complaint management databases/systems experience; strong written/verbal communication; Microsoft Office (spreadsheets/databases).
Preferred
- SPC/statistical analysis, Six Sigma, audits (internal/external/supplier), advanced trending/metrics dashboards, global post-market surveillance experience.
Benefits (as stated)
- Discretionary bonus; comprehensive healthcare, HSA, 401(k) up to 5% match, employee stock purchase plan (15% discount), paid time off, long-term incentives/stock awards.
- Manage end-to-end lifecycle of global customer complaints across multiple sites (intake, assessment, investigation, resolution, closure) with compliant MDR handling.
- Evaluate complaints for Medical Device Reporting (MDR) requirements; determine reporting obligations per FDA/ISO/EU MDR.
- Conduct root cause analyses, lead investigations, and write high-quality investigation reports.
- Use complaint management systems to document, track, trend, and report quality/complaint metrics.
- Monitor complaint trends; escalate potential quality/safety signals.
- Support Post Market Surveillance data collection, trending, and regulatory reporting inputs.
- Collaborate with clinical sites, physicians, hospitals, sales, and suppliers to gather complaint information.
- Support CAPA and Change Control (investigation support, documentation, effectiveness verification).
- Apply risk management principles (ISO 14971) and align with design/process controls.
- Maintain compliant complaint files (GDP); serve as trainer/SME; support audits and continuous improvement.
Qualifications / Required
- Bachelor’s in Engineering/Life Sciences or related, or equivalent experience.
- 3+ years complaint handling and quality systems documentation.
- Knowledge of FDA 21 CFR Part 820 and 21 CFR Part 211; ISO 13485; EU MDR 2017/745; global regulatory requirements.
- Experience with investigations/root cause analysis/documentation; CAPA/Change Control support.
- Risk/design control familiarity (ISO 14971).
- Analytical/problem-solving skills; interpret technical/quality data.
- Complaint management databases/systems experience; strong written/verbal communication; Microsoft Office (spreadsheets/databases).
Preferred
- SPC/statistical analysis, Six Sigma, audits (internal/external/supplier), advanced trending/metrics dashboards, global post-market surveillance experience.
Benefits (as stated)
- Discretionary bonus; comprehensive healthcare, HSA, 401(k) up to 5% match, employee stock purchase plan (15% discount), paid time off, long-term incentives/stock awards.