Regulatory Affairs Expert for Medical Devices in Chile
hace 2 días
About the Role
As a Regulatory Affairs Coordinator for Guerbet in Chile, you will play a crucial role in ensuring the timely completion and filing of regulatory submissions for medical devices and pharmaceuticals products. This position requires a strong understanding of the regulatory strategy of the company and the ability to manage regulatory submissions tracking process in Chile.
Key Responsibilities
- Coordinate the preparation and assembly of regulatory submissions for medical devices and pharmaceuticals products.
- Support in-country regulatory consultants and/or local distributors through Latin America to ensure filling of regulatory submissions to the respective regulatory bodies.
- Be aware of the regulatory strategy of the company.
- Manage regulatory submissions tracking process in Chile, establishing timelines for product maintenance submissions.
- Closely supervise regulatory consultants and/or local distributors in Latin America regarding the regulatory activities relating to Guerbet products.
- Coordinate with the local regulatory team the proper submission documents needed during the life cycle of the products in Chile.
- Interact with local regulatory bodies where needed or through local in-country consultants to discuss project feasibility, strategies to achieve fast-track approvals, and assess the impact of change control for the regional marketing authorizations.
- Ensure that all product lifecycle information (approvals, notices, rejections, or any other information with regulatory impact) are provided to Headquarters in a timely manner.
- Represent the Manager/Director in meetings of class entities and/or in meetings with regulatory bodies, as delegated.
About You
We are looking for a highly motivated and experienced Regulatory Affairs Coordinator who can provide expert guidance on regulatory submissions and ensure compliance with local and regional legislations. The ideal candidate will have a bachelor's degree or equivalent in health sciences, chemical pharmaceutical discipline, or related, with an active registration in the respective Regional Council. Previous experience as Technical Director in a pharmaceutical company is desirable.
What We Offer
As a Regulatory Affairs Coordinator for Guerbet, you will have the opportunity to work with a global leader in medical imaging and join a multicultural team of 2,600 people across more than 20 countries. We offer continued personal development and a collaborative work environment that values diversity of talents coming from various horizons.
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