Regulatory Affairs Specialist Bardi

Regulatory Affairs Specialist
Bardi
Emilia Romagna, Bardi

What we offer Opportunity to join a vibrant team in one of the top fast-growing companies in the dynamic field of Aesthetic Medicine.

Established in 2012 as a disruptive and scientifically-based medical aesthetics company, Neauvia has evolved into a high-growth international company supported by an iconic brand, innovative synergistic approach, production sites, and subsidiaries in more than 80 countries around the world.

Regulatory Affairs Specialist This position will report directly to the Regulatory Affairs Manager and will be in charge of preparing the necessary documentation to carry out all regulatory activities in the field of medical devices.

Core Responsibilities: Performs in collaboration with the regulatory team the management of the processing, issuing, and archiving of all documents necessary to carry out regulatory activity. Prepares all the necessary documents for authorizations for the production and/or marketing of products in compliance with the laws for CE and non-CE countries. Performs regulatory standard surveys for the commercialization of products in CE and non-CE countries, keeping regular contact with local distributors of the countries in which the DM is intended to be marketed. Collaborates in the drafting of the technical documentation to obtain and maintain the CE mark. Skills and Experience Needed for the Position: Specialist degree such as Chemistry, Physics, Biochemistry, Biotechnology, Pharmacy, Medicinal Chemistry, Biomedical Sciences, Biology (other qualifications are admitted subject to at least 2-3 years' experience in regulatory activities);Knowledge of spoken and written English;Knowledge of the use of computer systems;Knowledge of applicable regulations and standards: ISO 13485, MDR 2017/745, and MDCG guidelines;Strong organizational skills and commitment to completing projects;Ability to work under pressure and meet strict deadlines;Ability to work in a team.

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