Global Complaints Specialist
Wellspect HealthCare, Waltham, MA, United States
Job Summary
We are seeking a detail-oriented and highly motivated Global Complaint Specialist to join our Global Complaint Handling Unit – Post Market Surveillance team. This position plays a key role in ensuring timely and accurate disposition, intake and documentation of product complaints, supporting regulatory compliance, and collaborating across functions to enhance product quality and customer satisfaction. The ideal candidate brings a strong sense of accountability, excellent communication skills, and a desire to grow within the medical device and pharmaceutical industries.
This is an exciting opportunity for an early-career professional who is passionate about quality, regulatory compliance, and customer-centric problem solving within a global and highly regulated environment.
Responsibilities Complaint Intake and Documentation
Serves as the primary complaint initiator for the Global Complaint Handling Unit.
Accurately receives, evaluates, codifies, and documents product complaints in the designated complaint management system, ensuring all required data is captured in a timely and compliant manner.
Customer Communication
Conducts follow-up communication with complainants to support complaint investigations and gather additional information as needed.
Provides regular updates on complaint status and, when applicable, communicates final investigation findings to the complainant in a professional and empathetic manner.
Compliance
Ensures all complaint-handling activities are performed in accordance with applicable global regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, and EU MDR (Regulation EU 2017/745).
Adheres to internal policies, SOPs, and quality system requirements.
Contributes to the investigation process by collaborating with internal teams and supporting documentation efforts.
Participates in root cause analysis and recommends next steps as appropriate.
Corrective and Preventive Actions (CAPA)
Supports the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.
Reporting and Trending
Assists in tracking and trending complaint data.
Prepares reports and contributes data insights to support ongoing quality improvement initiatives.
Training and Knowledge Sharing
Provides guidance and shares best practices with internal teams on complaint handling processes.
Supports onboarding and training of new team members as needed.
Cross-Functional Collaboration
Partners with teams such as Engineering, Manufacturing, Regulatory Affairs, and Customer Service to resolve complaints effectively and drive continuous improvement.
Additional Duties
Performs other responsibilities as assigned in support of team and departmental goals.
Education
High School diploma or equivalent required.
Associate’s or Bachelor’s degree in a scientific, technical, or healthcare-related discipline preferred.
Experience
1–3 years of experience in a customer-facing or highly regulated role preferred.
Experience in a medical device, pharmaceutical, or other life sciences industry is a strong plus.
Key Skills, Knowledge, and Capabilities
Proficient in English; strong written and verbal communication skills required.
Multilingual abilities are highly desirable.
Excellent organizational skills and a high degree of attention to detail are fundamental to success.
Strong comfort level with computer-based tasks, including working across multiple systems or screens simultaneously.
Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.
Able to work both independently and collaboratively in a fast-paced, team-oriented environment.
Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.
Occasional travel may be required ( DentsplySirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status.
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This is an exciting opportunity for an early-career professional who is passionate about quality, regulatory compliance, and customer-centric problem solving within a global and highly regulated environment.
Responsibilities Complaint Intake and Documentation
Serves as the primary complaint initiator for the Global Complaint Handling Unit.
Accurately receives, evaluates, codifies, and documents product complaints in the designated complaint management system, ensuring all required data is captured in a timely and compliant manner.
Customer Communication
Conducts follow-up communication with complainants to support complaint investigations and gather additional information as needed.
Provides regular updates on complaint status and, when applicable, communicates final investigation findings to the complainant in a professional and empathetic manner.
Compliance
Ensures all complaint-handling activities are performed in accordance with applicable global regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, and EU MDR (Regulation EU 2017/745).
Adheres to internal policies, SOPs, and quality system requirements.
Contributes to the investigation process by collaborating with internal teams and supporting documentation efforts.
Participates in root cause analysis and recommends next steps as appropriate.
Corrective and Preventive Actions (CAPA)
Supports the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.
Reporting and Trending
Assists in tracking and trending complaint data.
Prepares reports and contributes data insights to support ongoing quality improvement initiatives.
Training and Knowledge Sharing
Provides guidance and shares best practices with internal teams on complaint handling processes.
Supports onboarding and training of new team members as needed.
Cross-Functional Collaboration
Partners with teams such as Engineering, Manufacturing, Regulatory Affairs, and Customer Service to resolve complaints effectively and drive continuous improvement.
Additional Duties
Performs other responsibilities as assigned in support of team and departmental goals.
Education
High School diploma or equivalent required.
Associate’s or Bachelor’s degree in a scientific, technical, or healthcare-related discipline preferred.
Experience
1–3 years of experience in a customer-facing or highly regulated role preferred.
Experience in a medical device, pharmaceutical, or other life sciences industry is a strong plus.
Key Skills, Knowledge, and Capabilities
Proficient in English; strong written and verbal communication skills required.
Multilingual abilities are highly desirable.
Excellent organizational skills and a high degree of attention to detail are fundamental to success.
Strong comfort level with computer-based tasks, including working across multiple systems or screens simultaneously.
Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.
Able to work both independently and collaboratively in a fast-paced, team-oriented environment.
Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.
Occasional travel may be required ( DentsplySirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status.
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