Archiviertes Projekt - RA specialist
Firmenname für PREMIUM-Mitglieder sichtbar
Please see below the JD and Qualifications expected:
* In this function the position is responsible for all RA deliverables linked to the management with focus on orthopedic systems.
* The RA Manager will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US and CAN.
* This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation.
* He/she will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes.
* The RA specialist/manager will support international product registration by consulting the responsible RA manager for international projects.
* Assessing, approval and release of communication material (IFU, leaflets, brochures). Assist other departments to ensure continued compliance and timely market release.
* Support of product development in cross functional teams
* Creation, review and/or approval of documents of the design control process
* Accountable for regulatory compliance
* Support international product registration
* Assessment, approval and regulatory implementation of change requests
* Review and approval of product related labeling and marketing material
* Support SAP based reporting systems
* Training internally on relevant procedures and requirements
* Understanding of regulatory requirements, applicability and implementation in practice
* Understanding for product development process and principles of design control
* Understanding for quality system requirements
* Development, review and release of all documents required for technical files
* Interpersonal skills and multitasking
* Work in SAP and office and Google based programs
* Technical or scientific background, university degree is an advantage
* Good Knowledge of medical device legislation EU ,US and CAN and corresponding guidelines
* Good knowledge of product development processes in MD industry
* Good knowledge of quality system requirements such as ISO 13485 and FDA's 21 CFR Part 820
* Fluent in English, further languages are an advantage
* Highly organized and able to work under strict time lines
* Strong interpersonal skills and proactive working attitude in an international matrix organization
* Excellent writing and communication skills
* Experience in preparation for notified body audits and FDA inspections are an advantage
* Experience in managing cross functional projects and teams (RA manager position)
* Minimum 2 to 5 years experience in regulatory affairs within the Medical Device Industry (depending on the role)
* Experience with EU, US and CAN medical Device regulations
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
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