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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Bringing out the best in people

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

Working at Dentsply Sirona you are able to:

**Develop faster** - with our commitment to the best professional development.

**Perform better** - as part of a high-performance, empowering culture.

**Shape an industry** - with a market leader that continues to drive innovation.

**Make a difference** -by helping improve oral health worldwide.

Job Summary

We are seeking a skilled and detail-oriented Global Post Market Complaint Reporting Specialist to join our Post Market Surveillance team. In this role, you will be responsible for evaluating product complaints and post-market data to determine regulatory reporting requirements, ensuring timely and accurate submissions to global health authorities. This position requires sound judgment, deep product understanding, and the ability to synthesize complex information to support regulatory compliance and patient safety.

Key Responsibilities:

_Complaint and Adverse Event Assessment_

+ Assess individual complaints for adverse events using sound judgment, product and clinical knowledge, and the totality of available information to determine regulatory reportability in alignment with global and regulatory requirements; document rationale clearly and escalate ambiguous cases as appropriate.

+ Acts as the in-country representative when filing for certain jurisdictions (e.g. US FDA).

+ Collaborates with global counterparts and other in-country representatives, Safety Officers or Persons Responsible for Regulatory Compliance (PRRC), to ensure timely and accurate reporting decisions are made and reports submitted to the appropriate competent authority.

_Regulatory Reporting_

+ Authors and submits high-quality, timely reports to health authorities (e.g., FDA, EMA, MHRA, TGA, Health Canada) in compliance with 21 CFR Part 803, EU MDR, and other applicable regulations.

_Post Market Surveillance Execution_

+ Supports a range of post-market surveillance activities, including field safety corrective actions, health hazard evaluations, and periodic report submissions (e.g., PSURs, PMCF, trend reports).

_Cross-Functional Collaboration_

+ Works closely with Regulatory Affairs, Safety Officers, Medical Affairs, Quality, Engineering, and other stakeholders to ensure accuracy and alignment in report content and decision-making rationale.

_Signal Detection and Trend Analysis_

+ Monitors complaint and adverse event data to identify potential safety signals or emerging trends requiring further investigation or escalation.

_Compliance and Audit Readiness_

+ Ensures all activities and documentation are audit-ready and consistent with global regulations, internal procedures, and good documentation practices.

+ Provides support and guidance to complaint handling team members, contributing to process consistency, training, and continuous improvement.

+ Supports audits or inspections with confidence and transparency.

_Continuous Improvement_

+ Proactively identifies and implements improvements to enhance reporting processes, data quality, and system efficiency.

_Communication and Transparency_

+ Communicate decisions and rationale effectively to internal partners and contribute to training and knowledge-sharing within the team.

+ Additional responsibilities as assigned.

Education:

+ Associate’s degree required; Bachelor’s degree preferred in fields including Life Sciences, Engineering, Dentistry, Pharmacy, Nursing, or a related technical discipline.

+ Advanced degree (e.g., MS, MPH, PharmD, MBA) is advantageous and may offset experience requirements.

Years and Type of Experience:

+ 3–5 years of experience in regulatory reporting, post-market surveillance, complaint handling, or pharmacovigilance in the medical device, pharmaceutical, or life sciences industry.

+ Demonstrated expertise in evaluating and reporting adverse events in accordance with international regulatory requirements.

Key Skills, Knowledge, and Capabilities:

+ Deep understanding and application of global reporting requirements (e.g., FDA 21 CFR Part 803, EU MDR, ISO 13485, MEDDEV 2.12-1) to complaint handling processes.

+ Strong decision-making capabilities, particularly in high-stakes or time-sensitive situations.

+ Exceptional analytical, written, and verbal communication skills.

+ Proficiency with complaint and safety data management systems (e.g., TrackWise, SmartSolve).

+ Meticulous attention to detail and commitment to data integrity.

+ Ability to thrive in a highly collaborative, fast-paced, and regulated environment.

+ Multilingual capabilities are a plus.

+ Occasional travel (<5% annually) may be required for training, audits, or cross-functional collaboration.

Dentsply Sirona is an Equal Opportunity/ Affirmative Action 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. We appreciate your interest in Dentsply Sirona.

If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected] ([email protected]) . Please be sure to include “Accommodation Request” in the subject.