Regulatory Affairs Specialist

Role Responsibilities

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  Develop and execute strategic regulatory plans for medical devices and combination products development programs across multiple global markets
• .Lead, prepare, author, and coordinate regulatory submissions including IDEs, 510(k)s, PMAs, technical files for CE marking, and other international registrations
• .Drive multiple cross-functional regulatory projects simultaneously to meet aggressive timelines and business objectives
• .Serve as liaison with regulatory authorities including FDA, Notified Bodies, and other global health authorities
• .Spearhead rapid response efforts to regulatory agency communications, including deficiency letters, requests for additional information, and pre-submission feedback; drafting clear, persuasive responses while managing tight turnaround time
• .Manage and update risk management files in accordance with ISO 14971, integrating regulatory considerations
• .Determine usability study requirements per IEC 62366 and coordinate human factors engineering activities
• .Generate regulatory analyses, GSPR/Essential Requirements checklists, and Declarations of Conformity (DoCs) as needed
• .Manage certificates, authorizations, and device registrations in accordance with applicable requirements
• .Architect and maintain regulatory watch systems to track changes in global medical device and biologics regulations
• .Monitor and interpret evolving regulations across jurisdictions, translating complex requirements into actionable guidance for cross-functional team
• sShape and maintain regulatory components of the QMS, ensuring alignment with ISO 13485, MDR 2017/745, and FDA QSR requirements
• .Drive and implement process and system improvements to optimize submission outcomes
• .Design templates, tools, and training materials to scale regulatory knowledge across the organization
• .Guide product development teams on regulatory requirements and optimal pathways from concept through commercialization
• .Participate in strategic planning sessions and design reviews as regulatory and quality subject matter expert, ensuring compliance throughout design control phases
• .Mentor team members on regulatory strategy and submission preparation
• .Support internal audits and regulatory inspections, serving as backup for quality-focused team members when needed
• .Coordinate regulatory aspects of clinical trials including regulatory authority notifications and approvals
• .Collaborate with quality colleagues to ensure seamless integration of regulatory requirements into manufacturing and post-market processes

.Key Qualification

• s
  Engineering Degree or equivalent in quality, regulatory and/or life scienc
• esMinimum 5 years of progressive regulatory affairs experience in the medical device indust
• ryDemonstrated expertise with FDA submissions and EU MDR requiremen
• tsExperience in preparing and conducting regulatory meetings (e.g. Pre-Subs, Pre-IND, etc
• .)Strong knowledge of global medical device regulations and ability to quickly navigate new regulatory framewor
• ksExperience with Class II-III (implantable devices) and biologics or combination produc
• tsProven ability to develop regulatory strategies for novel technologies and translate into actionable requiremen
• tsExcellent project management skills with ability to handle multiple complex projec
• tsExceptional interpersonal and communication skills with keen ability to work with cross-functional teams; able to influence at all organizational levels and across cultur
• esDemonstrated success managing parallel projects in a fast-paced environment, balancing compliance rigor with agile execution to meet aggressive timelin
• esStrong analytical and problem-solving capabilities with attention to deta
• ilAbility to travel (domestic and international; to various company locations and third-party site