Dentsply Sirona · 2 days ago
Global Post Market Complaint Specialist II
West York, PA
Full-time
Onsite
Mid Level
3+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The Global Post Market Complaint Specialist II will evaluate product complaints and post-market data to ensure regulatory compliance and timely reporting to global health authorities.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
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
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
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)
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
Monitors complaint and adverse event data to identify potential safety signals or emerging trends requiring further investigation or escalation
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
Proactively identifies and implements improvements to enhance reporting processes, data quality, and system efficiency
Communicate decisions and rationale effectively to internal partners and contribute to training and knowledge-sharing within the team
Additional responsibilities as assigned
Qualification
Required
Associate's degree required; Bachelor's degree preferred in fields including Life Sciences, Engineering, Dentistry, Pharmacy, Nursing, or a related technical discipline
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
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
Preferred
Advanced degree (e.g., MS, MPH, PharmD, MBA) is advantageous and may offset experience requirements
Multilingual capabilities are a plus
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
10001+ employees
H1B Sponsorship
Dentsply Sirona has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (14)
2023 (7)
2022 (14)
2021 (9)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$550M2025-06-05Post Ipo Debt· $550M
1987-08-21IPO
Leadership Team
Daniel Scavilla
President and Chief Executive Officer
Matthew Garth
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-16
2026-01-16
Company data provided by crunchbase