Regulatory Affairs Manager
- Experience Level
Our client is a pioneer in Drug Discovery and Development and one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. We are currently looking for an enthusiastic Regulatory Affairs Manager for a 12 month contract to be based in Rotkreuz.
As a Regulatory Affairs Manager you will need to have 3/4 years of experience in regulatory affairs, especially in in vitro diagnosis medical devices. This experience should be from the industry. We need someone with experience with hard and software regulations as well (experience with instruments rather than liquids or active substance).
- Provide regulatory support to the R&D Project teams with the applicable Design Control processes;
- Provide team members ad hoc specific education;
- Provide qualification and classification of the development object and related submission strategy;
- Interface with the correspondent RA-FL for submission strategies, planning and support;
- Escalate project related regulatory issues;
- Review labelling;
- Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts;
- Administrate Product declarations, Certificates and other, similar documents;
- Interact with other regulatory functions;
- Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest;
- Inform Global Regulatory Affairs Business areas about changes;
- Inform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management;
- Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products;
- Provide support for specific topic/questions;
- Define and provide Training on Regulatory submission topics;
- Monitor regulatory requirements, including communication and distribution in a level appropriate manner;
- Implement divisional and local-strategies.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Minimum 3/4 years in hands regulatory affairs in in vitro diagnostic medical devices;
- Experience in industry;
- Experience with hard and soft wares (working with instruments);
- Scientific degree (microbiology or chemistry) or an engineering degree;
- RWD knowledge / understanding.
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