Requirements: English
Company: HuFriedyGroup
Region: Fidenza , Emilia-Romagna
Join Our Team at HuFriedyGroup Innovating Excellencein Dental Instrument Manufacturing HuFriedyGroup is a leadingmanufacturer of dental instruments and infection preventionproducts. Our 10,000-plus products, hand-crafted by highly skilledartisans, are known for their precision, performance, longevity,reliability, and quality. To help dental professionals be The Bestin Practice, HuFriedyGroup provides a unique combination of worldclass products, value-added services, clinical education, anddental community platforms that result in superior clinicianperformance and enhanced safety for dental professionals and theirpatients. Working at HuFriedyGroup is so much more than a job, asevery employee has a part in driving and supporting theorganizations inspirational vision to be a global force inadvancing dental performance through Best-In-Practice dentistrythat improves lives around the world. Job Purpose: The RegulatoryAffairs Specialist is responsible for regulatory affairs andcompliance activities for HuFriedyGroup global markets. Executeregulatory affairs tasks to support achievement of businessobjectives. Determine regulatory pathway and requirements for newand revised products. Determine and define regulatory requirementsfor stakeholders throughout the company. Plan, develop, prepare andexecute regulatory submissions to regulatory agencies worldwide.Facilitate achievement of business objectives while ensuringcompliant operation within the flexibility of the regulations.Operate in matrix organization and collaborate with HuFriedyGroupcorporate regulatory affairs team to achieve corporate andenterprise business objectives.Facilitate HuFriedyGrouporganizational cohesiveness and compliance consistency andintegration of businesses. Responsible for both premarketregulatory and product development activities, internationalsubmission and postmarket regulatory activities. Facilitate andmanage in close collaboration with quality and compliance personnelinspections and audits by applicable regulatory agencies includingFDA, MDD, MDR, and EU Notified Bodies. Essential Duties andResponsibilities: - Execute regulatory affairs and complianceactivities for HuFriedyGroup product lines in worldwide markets. -Ensure company products, manufacturing operations, and analyticallaboratory practices comply with applicable regulatory and standardrequirements including US-FDA cGMP, EU Medical Device Directivesand Regulation, and ISO 13485 require ments. - Plan, develop,prepare and execute regulatory submissions to regulatory agenciesworldwide. Collaborate closely with HuFriedyGroup corporateregulatory affairs team to achieve corporate and enterprisebusiness objectives. - Partipation in ensuring design and processvalidations, and test methods analysis comply with applicableregulations and industry standards, such as US-FDA 21 cfr Part 820,EU MDR 2017/745 and ISO13485. - Review and determine regulatoryimplications of product, labeling, and/or other documentation ordesign changes. - Participate on project teams to providedregulatory leadership and input. Provide recommendations for how toovercome regulatory barriers and resolve any disputes within teamsas to the need and importance of regulatory requirements. -Collaborate with management in establishing departmental goals,strategies, and procedures in support of business objectives. -Participation in pre and post market regulatory and productdevelopment activities, international product registrations. -Facilitate, manage, and collaborate with quality and compliancepersonnel during establishment inspections and audits by NotifiedBodies and Competent Authorities; - Must be able to travel up to10% locally and internationally. Knowledge, Skills and Ability: -Degree in pharmaceutical chemistry or similar science or relatedtechnical discipline. - 3/5 years of regulatory experience withinUSFDA European Medical Device regulated industry. - Experience inplanning and preparing US-FDA 510K, MDD/MDR Technical Files, andinternational submissions is required. - Good English languageskills. - Demonstrated history of successful regulatory affairs andcompliance outcomes to support business objectives. - Knowledge ofUS-FDA Medical Device regulations, EU Medical Device Regulation,and ISO 13485. Familiarity with sterile packaged devicerequirements is a plus. - Strong written and verbal communicationskills, especially when dealing with governmental a gencies. -Ability to explain and resolve differences between and withinregulations. - Demonstrated experience in developmental andexecution of regulatory strategy.