REGULATORY AFFAIRS SPECIALIST (FDA)

iVascular is a fast growing company founded in 2010 in Barcelona (Spain) with the aim of developing medical devices and therapies for the treatment of disorders of the vascular system and to become a reference in the vascular field by enhancing the value of technology and innovation.The team that started iVascular has more than 30 years of experience in the field of vascular devices, being responsible for obtaining one of the first CE marks for a drug-eluting stent more than 20 years ago.We are currently looking for a Regulatory Affairs Specialist to strengthen our Regulatory Affairs team in their FDA projects.MISSION:The main mission of the Regulatory Affairs Specialist is to ensure we obtain registrations and market authorizations for medical devices manufactured by LVD Biotech-iVascular in the United States (FDA) are developed.MAIN RESPONSIBILITIES:Prepare, review, and submit technical and regulatory documentation in accordance with FDA requirements, including Premarket Approval (PMA), 510(k) submissions, and De Novo petitions.Ensure that all documentation complies with FDA regulations and internal quality standards.Collaborate with R&D and Clinical teams to design and manage preclinical and clinical trials.Act as the main contact point with the FDA and/or the authorized representative in the United States, as well as external consultants.Coordinate with R&D, Quality, and Operations teams to ensure regulatory compliance and product quality.Coordinate with the internal audit team to conduct internal audits and document reviews to ensure continuous compliance.Maintain the Device History Record (DHR) and Device Master Record (DMR) throughout the product lifecycle in accordance with FDA requirements.Stay updated with changes in FDA regulations and adapt internal processes accordingly.Provide training and guidance to team members on FDA regulations and processes.JOB PROFILE:Bachelor's Degree in the Life Sciences field (Medicine, Biology, Pharmacy, Engineering, Chemistry, or similar).Solid background working in the medical device sector in roles related to regulatory affairs.Proven experience in the preparation, submission, and management of applications for FDA approval, including Premarket Approval (PMA), 510(k) submissions, and De Novo petitions.Deep knowledge of applicable FDA regulations, including 21 CFR Part 820 (Quality System Regulations), ISO 13485, and other relevant standards.High degree of integrity and professional ethics.Effective, rigorous, dynamic, organized individual with high analytical and problem-solving skills.Excellent written and oral communication skills with the ability to interact with various internal and external teams.Ability to manage multiple projects simultaneously with a focus on deadlines and deliverables.Ability to prepare and review detailed technical and regulatory documentation.WHAT WE OFFER:Long term project with competitive salary package.A collaborative and close environment with teamwork culture.Possibility of projection in a company in fullexpansion.In-house physiotherapy service.Flexible compensation package.Catering service sponsored by the company.