Beschreibung
Aufgaben:* Execute regulatory affairs and compliance activities for Dental Division product lines in worldwide markets.
* Ensure company products, manufacturing operations, and analytical laboratory practices comply with applicable regulatory and standard requirements including US-FDA cGMP, EU Medical Device Regulation, and ISO 13485 requirements.
* Plan, develop, prepare and execute regulatory submissions to regulatory agencies worldwide. Collaborate closely with corporate regulatory affairs team to achieve corporate and enterprise business objectives.
* Ensure design and process validations, and test methods analysis comply with applicable regulations and industry standards, such as US-FDA 21 cfr Part 820, and ISO 13485.
* Review and determine regulatory implications of product, labeling, and/or other documentation or design changes.
* Participate on project teams to provided regulatory leadership and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
* Collaboratewithmanagement in establishingdepartmentalgoals, strategies, andprocedures in supportofbusinessobjectives * Responsibleforpreand post marketregulatoryandproductdevelopmentactivities, international productregistrations
* Facilitate, manage, and collaborate with quality and compliance personnel during establishment inspections and audits by US-FDA and Notified Bodies
Anforderungen:
* Degree in pharmaceutical chemistry or similar science or related technical discipline.
* 3-5 years of regulatory experience within EU Medical Device regulated industry.
* Experience in planning and preparing Technical Files under MDD and MDR, and international submissions is required.
* Knowledge of US-FDA Medical Device regulations, Medical Device Regulation, and ISO 13485. Familiarity with sterile packaged device requirements is a plus.
* Excellent Excel skills (usage of formulas)
* Demonstrated history of successful regulatory affairs and compliance outcomes to support business objectives.
* Experience in communicatingwithnotifiedbodies
* Fluent English language skills (written and spoken), Italian is a plus
* Strong written and verbal communication skills, especially when dealing with governmental agencies.
* Hands-on mentality