at Dentsply Sirona in Milford, Delaware, United States
Job DescriptionDentsply 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. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in the heart of Southern Delaware; located just 25 miles north of Rehoboth Beach and only 20 miles south of the state's capital, Dover. Also, we are centrally located east and south of Baltimore, Philadelphia and Washington DC. Whether standing at a scenic point along the downtown River walk, or spending the day at one of Delaware's beautiful beaches, know that underneath the calm tranquility is the energy of a community on the move!
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.
Summary: Responsible for the administration of the Milford Complaint Handling system, Medical Device (MDR), baseline and international medical device reporting (vigilance) and all filings as required for domestic and international regulations, and complaint investigations.
- Drives process improvement efforts and ensure compliance to FDA, European, Corporate and other international regulatory bodies regulations in his/her QMS processes and area of influence
Post Market Surveillance Oversight
- This role is responsible for coordination, documentation, and overall management of the post market surveillance system.
- Directs the planning, preparation and facilitates the timely submissions of all Medical Device Reporting, vigilance, and other regulatory reports to the appropriate regulatory authorities for Milford
- Provides guidance on clinical risks and outcomes associated with medical device malfunctions.
- Responsible for ensuring compliance with all regulatory reporting requirements.
- Communicates with customers to establish a full understanding of alleged adverse events.
- Enables rapid and effective escalation and investigation of potential safety related issues.
- Interacts with Regulatory Authorities to answer follow-up questions, provide investigation details.
- Analyzes medical device reporting data and complaint information to identify trends and notify designated internal personnel wi
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Equal Opportunity Employer–minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity