QA/Vigilance Specialist - MedTech/manufacturing -English/German
QA/Complaints specialist - Technical background - English a MUST, German useful - Swiss MedTech - permanent and key role
Our client is a globally active medical devices manufacturer - in a leading market position, growing, and with it the Quality department. On top of their 'wanted' list is a Vigilance specialist - a key role going forward, in addressing complaint and vigilance reporting processes, and ultimately in reducing the complaints themselves.
More specifically, this role will hold responsibility for vigilance reporting and assurance of the submission of the reports to regulatory agencies within required time lines. The person will drive the clarification of complaints including distributors to ensure they are correctly prioritised, and interact with health care providers and regulatory agencies to ensure all questions are addressed within established time-frames.
Importantly, a technical background will ensure a broad skills base within the department, to complement the clinical skills already present, and ideally allow better support of technical and manufacturing related issues, their resolution, and proactive communications with regulatory bodies.
- Immediate management of Field Safety Corrective actions and follow up
- Communication with Competent Authorities for incident reporting worldwide
- Acting as PMS SME in all internal and external audits
- Advice on new product development
- Preparation and management of all post market surveillance documentation as required by the MDR.
- Bachelor / MSc in technical field
- Several years experience managing post market activities (FSCA and vigilance) in a medical device company.
- Proven experience in interacting with the Competent Authorities all over the world.
- Strong knowledge of MDD 93/42 and regulations World-wide
- Knowledge of product complaints processes within the medical devices industry
- Fluency in English both written and verbal is essential
For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, and email him your resume in WORD format to firstname.lastname@example.org. For industry news and new opportunities in QA within the Medical Devices sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en
Keywords: Returned Devices Adverse Events, Incident reporting, Vigilance, post market, FSCA, Compliance, manufacturing, R&D, Research and Development, Quality Management, complaints handling, MDD, MDR, MEDDEV, Competent Authority, ISO 13485, Medical devices, QMS, CAPA, Switzerland, English, German, Nonstop Recruitment
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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