Otto Bock Healthcare Products GmbH zählt zu den international führenden Anbietern in der Medizintechnik. Unser Ziel ist Menschen ein Höchstmaß an Mobilität und Unabhängigkeit zu ermöglichen - Quality for Life. Bei uns steht der Mensch im Mittelpunkt!
We are looking to strengthen our team in the field of Regulatory Affairs and are seeking to recruit at the earliest opportunity a
Regulatory Data Management Expert (m/f)
- Establish objective and transparent data specifically pertaining to the Voice of the Customer (VOC) and the Voice of the Process (VOP) across Medical Device regulatory relevant processes.
- Establish and evolve data requirements, data definitions, data gathering, data evaluation, data analysis for regulatory relevant processes in support of attaining market submissions and maintenance of market approvals.
- Support data quality, integrity and compliance to regulatory regulations
- Support data transparency of the complaint management process e.g. customer feedback, complaints, risk handling, customer satisfaction
- Establish identity as the Subject Matter Expert (SME) in this area of expertise
- Identification, qualification, selection and prioritization of process and system improvement opportunities in line with Ottobock business strategy.
- Support KPI's identification, monitoring, trending and reporting to visualize the VOC and the VOP across all Medical Device regulatory relevant processes.
- Link KPI's and impact of improvement opportunities to support successful achievement of financial and business objectives.
- Communicate analysis findings to senior management and stakeholders in business language, delivering objective, meaningful and insightful presentation.
- As required provide mentoring for divisional analysts and trending specialists.
- As required support Project Management in tasks such as resource availability, adherence to schedule and work package prioritization.
- Master's Degree with a focus on the development of an analytical skillset.
- 3+ years of experience in a regulated industry, preferably medical device.
- Knowledge of regulations pertaining to the commercialization of medical devices and the working practices of international agencies including FDA QSR, ISO 13485, MDD, CMDCAS, SFDA, JPAL MHLW, ANVISA amongst others.
- Qualification in quality methodologies including Six Sigma, Lean Principles, Advanced Statistical Techniques and Reliability Techniques and other proven tools is advantageous.
- Experience in analysis of Complaint Handling, Customer Data, Field Data, process performance.
- Experience with structured/unstructured data preconditioning, data quality assessment, statistical data analysis, data-mining of processes, products and services.
- Working knowledge of SAP, SQL
- Scripting skills in R, Python or Matlab and understanding of reporting tools such as Qlikview, Tableau are of advantage
- Attention to detail, structured thinking, ability to see the big picture
- Strong communication/stakeholder involvement skills with employees at all levels
- Fluent German and English
What we offer
Your ideas and commitment will inspire your colleagues and staff, and will further the interests of Ottobock. We look forward to receiving your application! Be part of a dynamic, growing company with flat hierarchies. We offer a richly diverse field of work, individual development opportunities and extensive qualification programs in our Ottobock Academy. You can expect an annual gross salary from EUR 50,000.-, overpayment depending on the specific qualification and experience!
We request that you only apply via our online career portal https://stellenangebote.ottobock.de/cgi-bin/appl/selfservice.pl?action=jobdetail;job_pub_nr=50331076-3A83-4FFC-9A53-BEA493E088FA;p=homepage. Please quote the reference number for the position in question, and also state your earliest starting date and salary requirements.
Please ignore the application link below, instead please use the link mentioned above. We are looking forward to your online application.
Otto Bock Healthcare Products GmbH
Recruiting - Brehmstraße 16 - 1110 Wien