.At Alcon, we are driven by the meaningful work we do to help people see brilliantly.
We innovate boldly, champion progress, and act with speed as the global leader in eye care.
Here, you'll be recognized for your commitment and contributions and see your career like never before.
Together, we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
The Senior Regulatory Affairs 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, a typical day will include: Regulatory Compliance: Ensure all products (medical devices, medicinal products, cosmetics, and food supplements) meet applicable regulatory and normative requirements for marketing.
Product Notification and Registration: Handle product notification, registration, and approvals, including translations, labeling, and promotional material compliance.
Launch Coordination: Work with corporate and manufacturing teams to anticipate and complete regulatory actions on time for product marketing.
Clinical Investigations: Manage and submit clinical investigation applications and other studies involving medical devices, as applicable.
Registration Maintenance: Continuously update and maintain the registration status of devices and medicinal products to remain compliant.
Regulatory Updates: Stay informed about local regulatory changes and communicate updates to regional/global regulatory affairs teams.
Labeling and Documentation: Oversee translations, reviews, and approvals of directions for use, operator manuals, and labeling for compliance.
Promotional Material Oversight: Review and approve promotional materials to ensure regulatory compliance.
Regulatory Systems Management: Manage regulatory systems, databases, and electronic applications for both medical devices and medicinal products.
Health Authority Communication: Handle electronic communications with local health authorities regarding medical devices, ensuring timely and accurate submissions.
WE ARE SEEKING: Bachelor's degree related to Health Sciences.
Master's Degree in the Pharmaceutical Industry is an asset.
Minimum 3 years of experience in Regulatory Affairs and in Medical Devices and minimum 1 year of experience in Medicinal products.
Ability to fluently read, write, understand and communicate in English and Spanish.
Results-Oriented and multitasking ability: Demonstrates a strong focus on achieving objectives and skilled at managing multiple priorities.
Team Collaboration and collaborative mindset: Works effectively as part of a team, fostering a cooperative and supportive atmosphere