Regulatory Affairs Specialist
hace 10 horas
We are a global leader in eye care, driven by our mission to help people see brilliantly. Our innovative spirit and commitment to progress enable us to make a meaningful impact in the lives of our patients and customers.
Job Title: Regulatory Affairs Specialist - Medical Devices and Medicinal ProductsAbout the Role:This role is based in Cornella de Llobregat and involves 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.
About You:To be successful in this role, you will have a Bachelor's degree in Health Sciences and at least 3 years of experience in Regulatory Affairs, with a focus on Medical Devices. A Master's Degree in the Pharmaceutical Industry is an asset. Your proficiency in English and Spanish will enable you to effectively communicate with local health authorities and cross-functional teams.
Responsibilities:- Ensure all products meet applicable regulatory and normative requirements for marketing
- 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 of 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
- Health Authority Communication: Handle electronic communications with local health authorities regarding medical devices, ensuring timely and accurate submissions
- Bachelor's degree in Health Sciences or related field
- Minimum 3 years of experience in Regulatory Affairs, with a focus on Medical Devices
- Master's Degree in the Pharmaceutical Industry is an asset
- Ability to fluently read, write, understand, and communicate in English and Spanish
- Comprehensive benefits package
- Training and continuous development opportunities
- International exposure
- Open, friendly, and collaborative culture
- Opportunity to work in a challenging environment with an outstanding team that will support you to achieve your goals and performance
$60,000 per annum, based on location and industry standards.
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