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Archiviertes Projekt - Regulatory Affairs Specialist

Firmenname für PREMIUM-Mitglieder sichtbar

November 2020

Juli 2021

CH-Schweiz

auf Anfrage

27.10.2020

RE-33586310_1603788993

Projektbeschreibung

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: 11/2020
* 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.

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