Post Market Surveillance Specialist
Dentsply Sirona - Ballaigues
12.06.2019 | Employee | 100%

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.  As The Dental Solutions CompanyTM, Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry.  Dentsply Sirona’s global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria. 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. 

Post Market Surveillance Specialist

MISSION

Support the Quality Assurance & Regulatory Affair department by reviewing, evaluating, and performing Post Market activities on our medical devices, determining if they require vigilance reporting, trend reports, identifying supporting data and notifying regulatory agencies as necessary.

Support the team regarding complaint handling activities in accordance with company guidelines, regulatory requirements and standard ISO 13485, European Regulation (MDR), FDA 21 CFR part 820-803.

 

MAIN RESPONSIBILITIES

  • Act as an interface between Product Surveillance team and Regulatory, Quality, Clinical, R&D and Marketing team to gather appropriately PMS data.
  • Collect, trend and escalate data related to Post Market Surveillance.
  • Preparation and presentation of Post Market Surveillance Report to the Management
  • Generate, maintain and complete the Post Market documentation (Periodic safety update report, PMS report & Plan) subject to review by regulatory agencies.
  • Ensure that Post Market procedures, processes and documentation meet the required compliance guidelines and regulations
  • Support Product Surveillance system activities and trainings
  • Ensure preparation of analytical reports and statistics periodically or upon specific request.

PROFILE

  • Successful Bachelor’s degree in life science or engineering (or related field)
  • Good knowledge of European Medical Device Regulation
  • 1 to 2 years tin post-market surveillance and complaint management of medical devices (Complaint Evaluation / Safety assessment / Medical Device Reporting / Compliance).
  • Language: English (C1) & French (B1 minimum), German knowledge is an asset
  • Ability to work autonomously and accurate in every detail
  • Strong organizational, planning and analytical skills, results oriented.
  • Excellent communication and interpersonal skills, ability to work in international environment with cross-functional team
  • IT Tools: Excel (advanced), Word, Power Point, ERP (Microsoft Dynamics)
  • Experience with software’s such as TrackWise

12.06.2019
Employee, 100%

Contact

Dentsply Sirona
Caiazza Annelise
Ch. Du Verger 3
1338 Ballaigues
Dentsply Sirona
Ch. Du Verger 3
Ballaigues

Industry

Biotechnology / Chemistry / Pharmaceutical
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