Beschreibung
Regulatory Affairs SpecialistPlease 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.