Regulatory Affairs Expert for Medical Devices and Medicinal Products
hace 4 días
**Company Overview**
At Alcon, we strive to make a meaningful impact in the lives of our patients and customers by innovating boldly and championing progress. As the global leader in eye care, we foster an inclusive culture that values diversity and talent.
**Job Description**
The Senior Regulatory Affairs Specialist is responsible for planning, organizing, and managing regulatory activities related to medical devices, medicinal products, cosmetics, and food supplements for the Surgical and Vision Care divisions in Spain.
This position is based in Cornella de Llobregat. In this role, you will:
- Ensure all products meet applicable regulatory requirements;
- Handle product notification, registration, and approvals, including translations, labeling, and promotional material compliance;
- Work with corporate and manufacturing teams to anticipate and complete regulatory actions on time for product marketing;
- Manage and submit clinical investigation applications and other studies involving medical devices, as applicable;
- Continuously update and maintain the registration status of devices and medicinal products to remain compliant;
- Stay informed about local regulatory changes and communicate updates to regional/global regulatory affairs teams;
- Oversight translations, reviews, and approvals of directions for use, operator manuals, and labeling for compliance;
- Review and approve promotional materials to ensure regulatory compliance;
- Manage regulatory systems, databases, and electronic applications for both medical devices and medicinal products;
- Handle electronic communications with local health authorities regarding medical devices, ensuring timely and accurate submissions.
**Required Skills and Qualifications**
To be successful in this role, you should have a Bachelor's degree related to Health Sciences, preferably with a Master's Degree in the Pharmaceutical Industry. A minimum of 3 years of experience in Regulatory Affairs and 1 year in Medical Devices, as well as fluency in English and Spanish, are essential.
**Benefits**
We offer a competitive salary range of **€50,000 - €65,000** per annum, depending on experience, plus benefits and opportunities for career growth.
**Location**
Cornella de Llobregat, Spain.
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