Beschreibung
Regulatory Affairs Specialist (f/m/d)For our client, a market leader in the Medical Device industry, I am currently selecting Regulatory Affairs Specialist who can support with the development and execution of regulatory strategies.
Key facts:
- Start Date:
- Length: 9 months
- Workload: 100%
- Location: Central Switzerland
Tasks:
- Support of RA processes related to imported/distributed products (=3rd party legal manufacturer products) for CE, US and CA.
- Support development and execution of regulatory strategies for development projects of distributed products, product change projects, compliance projects and lifecycle management activities.
- Execution of lifecycle management activities related to distributed products (change management, implementation of MDR obligations as distributor/importer, supply chain analysis)
- Ensure completion registration/notifications in local EU registers
- Provide regulatory guidance in projects related to distributed products under guidance and supervision
- Assessment of compliance status to applicable regulations (i.e. EU, US, CA) of distributed products
- Review and approval of product related labeling, IFUs and marketing material and associated claims under guidance and supervision
Knowledge, skills & Experience
- Min. of 2 years of experience in medical devices with good experience in regulatory affairs
- Very good knowledge of new EU MDR, good knowledge of EU, US, and CA medical device regulation
- Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
- Understanding of general medical device supply chain specifics and operational distribution network requirements
- Understanding of contractual agreements related to supply chain (distribution agreements, quality/regulatory agreements between manufacturer and distributor)
- Knowledge of design control process requirements and requirements for technical documentation for medical devices.
- Knowledge in documentation requirements and processes for CE, US and CA submissions
- Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485
- Knowledge of quality and regulatory systems and processes from a system perspective.
- Hands-on and communicative
- Ability to work in an international matrix organization
- Project management skills
- Fluency in English / German is an advantage
- Knowledge of SAP including systems understanding data handling and office based systems, especially Excel
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.