Manager PMS / Clinical Evaluations (m/w) in Basel
|Job Title:||Manager PMS / Clinical Evaluations (m/w) in Basel|
|Contact Name:||Petra Ognjenovic|
|Job Published:||April 04, 2018 11:21|
Manager PMS / Clinical Evaluations (m/w) in Basel
Do you have the ability to work accurately and effectively under pressure and to prioritize workload. Are you a decisive, communicative, team player. Is your strength being assertiveness, pragmatic and solution oriented? Perfect, as we are looking for a proactive new team member who is able to successfully maintain a network of productive relationships in the dental implants industry.
- Carry out Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) activities and write Clinical Evaluation plans and reports within the Research Team of the R&D Department of our client which is a Biotech company
- Compile and up-date PMS / PMCF plans and reports as well as Clinical Evaluation plans and reports in a timely manner and in accordance with EU directives for medical devices and related guidelines.
- Actively support and implement the transition from current MDD to MDR in relation to PMS, PMCF (post market clinical follow-up) and Clinical Evaluation activities, including new reporting requirements under MDR.
- Support of the project teams and of the regulatory affairs team with clinical evaluation activities, which are required in local markets (e.g. China).
- Drive the compilation of Clinical Evaluation Plans and Reports according to the requirements of MEDDEV 2.7/1 Revision 4
- Take responsible for setting up PMS & PMCF plans according to the requirements of European regulations for medical devices
- Compile and up-date PMS & PMCF reports in a timely manner
- Ensure that sufficient pertinent clinical data for all medical devices of our clients product range are available.
- Systematically update the collection of pertinent clinical data, which includes (inter alia):
- periodic systematic literature search
- up-date of sales & complaint statistics
- evaluation of sales reports regarding customer feedback on own & competitor products
- evaluation of data from competent authorities on reportable events (own and competitors products)
- Actively support project teams during the Clinical Evaluation process for new products and provide consultancy regarding the Clinical Evaluation strategy.
- Support the RA team in respect to Clinical Evaluation and PMS activities in local markets (e.g. China).
- Provide support to the implementation and documentation of Change requests and Product Extension projects, ensure the integration of such products in existing CEP, CER & PMS / PMCF documentations
- Provide support and advise the Brand Management in the interpretation of PMS / PMCF requirements
- Participate in interdisciplinary development projects
- Participate in special projects
- Master degree in science, medical, or engineering or relevant industry experience., Ph.D. is an advantage
- Completed professional formation plus a minimum of 5 years of work experience in the medical device industry or in a related field.
- ideally 1- 3 years experience in PMS / PMCF, clinical evaluation writing, or RA environments, experience in the dental field is a plus.
- Experience in quality management, product development, testing and manufacturing of medical devices is a plus.
- Experience in working in a multi-project environment
- Excellent verbal and written language skills both in German and English is a must, any other language is an advantage
- Excellent MS Office skills, SAP a plus
- Experience with literature search in relevant data bases
If you are interested, please send you documents to: email@example.com.
In case of any further question, please feel free to contact Petra Ognjenovic directly: +41 435089217.
"Here at SciPro Munich we are covering the key roles within the Life Science industry that require a great amount of skill and dedication. Using the professional guidance of experts who work each and every day with Global leaders in both Medical Device and Pharmaceutical areas, clients will have the choice of supreme candidates, while candidates will be given the chance to land the job that their hard work deserves. The German Life Science industry is booming, and it is clear that high quality candidates are in high demand. Through second to none consultancy, and a hands on approach, we will give you a valuable boost in securing your perfect match carefully selected to fit your requirements. Furthermore, we are fully aware of the pressure concerned with the new MDR, and that there is more of a need than ever to have excellent talent to prepare for the inevitable addition of workload within various departments. Finally, we are extremely proud of our international presence, and with the increasing Globalization of the Life Science industry, we fully understand the need for internationally qualified professionals - however specialized your need is, we have you covered!"