As a Regulatory Affairs professional, you will lead regulatory strategy for medical devices and drug-device combinations.
You will serve as the regulatory representative for global project teams and drive interactions with health authorities and Notified Bodies.
You will oversee regulatory activities across the device development lifecycle and ensure compliant submissions.
This role supports Parexel's mission to improve world health by enabling patient access to therapies.
You will work across regions, including EU MDR-focused tasks, in a flexible home/office setup.Scopra se questa occasione è adatta a lei leggendo tutte le informazioni riportate di seguito.Develop regulatory strategies and create technical documentation for medical devices and combination productsRepresent regulatory affairs in global project teams and governance meetingsLead interactions with health authorities and Notified Bodies, including documentation and meeting coordinationManage regulatory activities throughout device clinical development and marketing authorization lifecycleMaintain global regulatory databases with up-to-date informationCollaborate with CMC and QA on device change control and global submission requirementsSupport internal and external audits related to medical device quality systemsCoordinate with cross-functional teams to ensure timely,



compliant regulatory submissionsContribute to continuous improvement, innovation, and strategic planning within regulatory functionUniversity degree in a scientific discipline or life sciences field; minimum 5+ years of regulatory affairs experience for medical devices and drug-device combinationsIn-depth knowledge of global medical device regulations, especially EU MDR; familiarity with US FDAis a plusProven experience in global regulatory strategy and technical documentation for EU (clinical investigations, Notified Body opinions, CE certifications)Familiarity with EU-MDR, ISO *****, ISO *****; experience with in vitro diagnostic devices a plus xysqume Strong track record in regulatory audits and inspections; excellent communicationand interpersonal skillsFluent in English, written and spokenProficiency with regulatory systems like Veeva and TrackWise a plusExcellent communication and interpersonal skillsCross-functional collaborationaudit and inspection readinessRegulatory strategy for medical devices and combination productsRegulatory documentation for EU and Notified BodiesEU MDR knowledgeRegulatory Affairs Consultant: Medical Device and Combination Product Expert pavia, lombardia, it#J-*****-Ljbffr

📌 Regulatory Affairs Consultant: Medical Device And Combination Product Expert (Bardi)
🏢 Parexel
📍 Bardi