Regulatory Affairs Specialist

Join Our Team at HuFriedyGroup – Innovating Excellence in Dental Instrument Manufacturing

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

Job Purpose:

The Regulatory Affairs Specialist is responsible for regulatory affairs and compliance activities for HuFriedyGroup global markets. Execute regulatory affairs tasks to support achievement of business objectives. Determine regulatory pathway and requirements for new and revised products. Determine and define regulatory requirements for stakeholders throughout the company. Plan, develop, prepare and execute regulatory submissions to regulatory agencies worldwide. Facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations. Operate in matrix organization and collaborate with HuFriedyGroup corporate regulatory affairs team to achieve corporate and enterprise business objectives.Facilitate HuFriedyGroup organizational cohesiveness and compliance consistency and integration of businesses. Responsible for both premarket regulatory and product development activities, international submission and postmarket regulatory activities. Facilitate and manage in close collaboration with quality and compliance personnel inspections and audits by applicable regulatory agencies including FDA, MDD, MDR, and EU Notified Bodies.

Essential Duties and Responsibilities:

• Execute regulatory affairs and compliance activities for HuFriedyGroup 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 Directives and Regulation, and ISO 13485 require ments.
• Plan, develop, prepare and execute regulatory submissions to regulatory agencies worldwide. Collaborate closely with HuFriedyGroup corporate regulatory affairs team to achieve corporate and enterprise business objectives.
• Partipation in ensuring design and process validations, and test methods analysis comply with applicable regulations and industry standards, such as US-FDA 21 cfr Part 820, EU MDR 2017/745 and ISO13485.
• 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.
• Collaborate with management in establishing departmental goals, strategies, and procedures in support of business objectives.
• Participation in pre and post market regulatory and product development activities, international product registrations.
• Facilitate, manage, and collaborate with quality and compliance personnel during establishment inspections and audits by Notified Bodies and Competent Authorities;
• Must be able to travel up to 10% locally and internationally.

Knowledge, Skills and Ability:

• Degree in pharmaceutical chemistry or similar science or related technical discipline.
• 3/5 years of regulatory experience within USFDA – European Medical Device regulated industry.
• Experience in planning and preparing US-FDA 510K, MDD/MDR Technical Files, and international submissions is required.
• Good English language skills.
• Demonstrated history of successful regulatory affairs and compliance outcomes to support business objectives.
• Knowledge of US-FDA Medical Device regulations, EU Medical Device Regulation, and ISO 13485. Familiarity with sterile packaged device requirements is a plus.
• Strong written and verbal communication skills, especially when dealing with governmental a gencies.
• Ability to explain and resolve differences between and within regulations.
• Demonstrated experience in developmental and execution of regulatory strategy.