You will be responsible for regulatory support to market orthopaedic products. General function: - Coordinates and manages international (EU, FDA) regulatory submission process; may author and publish electronic submissions. - Coordinates and manages the development of dossiers for global registration of products; may author and publish electronic submissions. - Provides regulatory direction; develops regulatory strategy for new products. - Oversees development and review, proposed labelling for compliance with applicable EU, US and international regulations. - Supports, supervises, and participates in the development of the information for use and package inserts, evaluation of promotional and advertising material for compliance with applicable regulations, and reviews of proposed product changes. - Ensure compliance with company RA policies. - Communicates with Regulatory, Government and Certification bodies.
- At least 2 years of RA experience, preferably in the medical technology area. Included regulatory submission, dossiers registration, interacting with R. agencies and reviewing labelling. - Scientific or Engineer degree. - Demonstrated strong writing and communication skills, ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors and peers. - Fluency in English, any further european language desiderable. - Strong attention to details and ability to multitask. - Functional knowledge of relevant regulatory legislation and ability to stay abreast of both vertical and horizontal regulations to medical devices, biologics, drugs and combination products. - Strong medical products knowledge. - Ability to negotiate and to work indipendently. Michael Page Contact : Your application will be sent to Stefano Chiei Gamacchio (Zurich office), lpease quote the job reference KSCH29527.
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