Our client a leading pharmaceutical organization, is seeking a Senior Regulatory Associate for their Medical Device division. Your role will be to interact with the Notified Body and Competent Authority. You will provide regulatory support and expertise by developing European regulatory strategies and submissions. Your responsibilities include creation and maintenance of essential requirement check lists, technical files, and declarations of conformity. You will also be responsible for the coordination of vigilance and field action reporting, commenting on proposed regulations, and representation of the company's interest in the development of standards and guidelines. You will also provide regulatory advice and support in relation to the registration and conformity assessments of medical devices in the EMEA region and be a liaison with regulatory agencies and notified bodies. You will assist in the preparation of agency meeting packages and strategies for agency meetings and evaluate manufacturing and labelling changes, promotional materials for regulatory impact and EMEA labelling review and approval. You will be the local regulatory contact for the EMEA Medical Device commercial team, perform due diligence on local in-licensing opportunities for medical devices and local due diligence for in-licensed EMEA only projects.
As the ideal candidate, you will hold a science related degree or similar qualification. You must currently be or have a background with a minimum of 5 years' experience within a Regulatory Affairs role for the medical device industry.
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