Senior Regulatory Specialist

Role 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 teams.
• 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.
• Collaborate with quality colleagues to ensure seamless integration of regulatory requirements into manufacturing and post-market processes.
• Coordinate regulatory aspects of clinical trials including regulatory authority notifications and approvals.

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)

Preferred Qualifications

• Experience with neurological devices or active implantables
• Knowledge of biologics regulations (BLA, IND) for combination products
• Familiarity with regulatory requirements in global markets
• Experience with MDSAP, ISO 13485 certification processes
• Regulatory certification (RAC) or advanced degree in regulatory science
• Experience in startup or fast-paced environments
• Proficiency with electronic QMS, PLM, and project-management tools (e.g., Asana).
• Proficiency in additional languages