Regulatory Affairs Specialist

Regulatory Affairs Specialist Plans, organizes and implements strategies and activities required to procure regulatory approval for new and revised product lines. Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDR Technical Files and other international registrations. Ensure compliance to all US, EU and international requirements and company policies and procedures regarding submissions and other requirements for market approval of medical devices. 1st Shift: Monday-Friday 8:00 am-5:00 pmAuthors, compiles, and submits regulatory documents to obtain approval to market new or modified products, including 510(k) premarket notifications and international submissions. Prepares, maintains and submits Technical Documentation and Declarations of Conformity for CE-marked products under EU MDR 2017/745. Prepares and maintains international product registrations. Prepares and updates US FDA product listings and establishment registrations. Monitors publications and activities of FDA, EU Commission, and international regulatory bodies to identify and respond to new or revised regulatory requirements affecting company products. Interprets existing and emerging regulatory requirements as they relate to company products and procedures; communicates updates to appropriate personnel and management. Identifies and communicates changes to domestic and international regulatory requirements in a timely manner to support proactive compliance planning. Ensures label claims and content of promotional and marketing materials comply with domestic and international regulatory requirements; reviews and recommends appropriate changes. Provides regulatory support to new product development teams to ensure US and international regulatory requirements are incorporated into the development process from design input through commercialization. Performs and documents regulatory assessments for modifications to existing devices, collaborating with marketing, R&D, and operations on proposed changes. Supports marketing and new product development in regulatory assessments of proposed labeling, design, or manufacturing changes. Collaborates with engineering and operations teams on design controls, validation activities, and technology transfers. Bachelor's degree or higher in a life science, engineering, or related discipline from an accredited institution. Minimum of 35 years of regulatory affairs experience in the medical device industry. Solid knowledge of US FDA regulations including 21 CFR Parts 820 (QSR/QMSR), 803, 806, and 807. Working knowledge of EU MDR 2017/745, including Technical Documentation requirements and Declaration of Conformity preparation. Experience with ISO 13485 quality management system requirements. Direct experience with Class II or III EU MDR submissions and Technical Documentation under EU MDR 2017/745. Ability to correctly interpret regulations and apply them to day-to-day business operations. Strong written and verbal communication skills; ability to interact effectively with individuals in scientific, technical, and regulatory fields. International device registration experience (EU, Asia-Pacific, Australia, or other markets). Familiarity with ISO 14971 risk management. Knowledge of 510(k), MDR, and CE Marking requirements with active role in submissions leading to commercialization. Familiarity with global and regional trends in regulatory affairs. Strongly prefer candidates with Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) or equivalent professional certification. Ability to interact with individuals in scientific and/or technical fields International device registration experience (preferably EU, Asia, Canada etc.) Ability to effectively negotiate and balance the need for regulatory compliance with the needs of the business Ability to correctly interpret regulations as they apply to day to day business operations.