Descripción
Freelance/temporary employment for a project
Bern
Start date: asap
Reference number: 781914/1
### Responsibilities ###
* Maintain knowledge of relevant legislation, regulation, and industry trends in the field of Medical Devices and Combination Products
* Maintain own specialist expertise through exposure, education, training, and application
* Assure that design verification is performed according to current scientific rational, regulatory /internal guidelines, legal requirements and quality standards
* Ensuring data integrity and scientific consistency in all verification testing
* Promote data analyses using advanced statistical techniques and communicate results to a cross-functional team
* Application of knowledge pertaining to regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support
* Ensure R&D efforts related to the development of new products and design modifications to existing products follow the appropriate Design Control procedures as mandated by Health Authorities
* Support of reports review of final reports, data, questions for regulatory submissions/filings
* Support with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions
* Supporting the creation, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes
### Profile ###
* Well-founded experience in Pharma Device Development
* University degree, in a relevant field of science e.g. engineering, in biotechnology / biochemistry / biology or corresponding qualification based on work experience in a relevant field
* Strong scientific background in all aspects of primary packaging and drug delivery
* Necessary: education and experience to understand and comply with Worldwide Combination Product and Medical Device Regulations
* Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies
* Experience with test method development, Combination Product Verification Testing, and specification generation
### Benefits ###
* A highly motivated team and an open way of communication
* A very renowned company