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Key Responsibilities:
Assist the complaint teams in Denmark and Mexico related to complaint handling.
Participate in meetings related to complaint handling with various customers.
Send out monthly reports to various internal and external customers.
Responsible for providing complaint data trend input to Post Market Surveillance Report.
Assist in different Ad Hoc tasks within the QA/RA department.
Keep up-to-date with the latest data management.
Use business intelligence in all aspects of complaint handling.
Trending and monitoring according to Article 88 of the Medical Device Regulation (MDR) 2017/745 The DTS is obligated to report and document all data related to: forecasting; reporting (Analysis of data); trending.
EU MDR In addition the DTS is to give a precise view of the business in statistical terms and answer the foreign authorities regarding any statistical questioning within the scope of complaint handling. The DTS is to provide statistical material according to regulatory demands of any authority or agency as well as any requirement from customers. In addition, the CDA is to validate and document the work for future analysis.
Key requirements
Personal Profile:
Minimum 3 years of experience from similar job.
Familiar with the use of MS Office.
Power BI experience (preferred).
Data handling, analytics and investigations.
Experience with ERP and TrackWise (preferred).
Fluent English, written and verbal.
Key Experiences:
Training in EU MDR, ISO 13485 and MDSAP.
Min. 3 years quality management system handling experience.
Organization/BU/Function information
Denmark, Infusion care
Geographical scope: single country
Languages
Speaking: Yes English*
Writing/Reading: Yes English*
Working conditions
Hybrid working – 1-2 number of days per week in the office driven by business requirements as Convatec has a flexible approach to office working .
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
#LI-SF1
#LI-Hybrid
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
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