Regulatory Affairs Specialist

Responsibilities 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 Shape 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 Qualifications Engineering Degree or equivalent in quality, regulatory and/or life sciences Minimum 5 years of progressive regulatory affairs experience in the medical device industry Demonstrated expertise with FDA submissions and EU MDR requirements Experience 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 frameworks Experience with Class II‑III (implantable devices) and biologics or combination products Proven ability to develop regulatory strategies for novel technologies and translate into actionable requirements Excellent project management skills with ability to handle multiple complex projects Exceptional interpersonal and communication skills with keen ability to work with cross‑functional teams; able to influence at all organizational levels and across cultures Demonstrated success managing parallel projects in a fast‑paced environment, balancing compliance rigor with agile execution to meet aggressive timelines Strong analytical and problem‑solving capabilities with attention to detail Ability to travel (domestic and international; to various company locations and third‑party sites) #J-18808-Ljbffr