RA specialist

Zürich  ‐ Vor Ort
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Beschreibung

Regulatory Affairs Specialist

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


Qualifications
  • 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.
Start
03/2020
Von
Real Staffing
Eingestellt
06.03.2020
Projekt-ID:
1905108
Vertragsart
Freiberuflich
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