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Science · 1 day ago

Senior Regulatory Specialist

Alameda, CA

Full-time

Onsite

Senior Level

$140K/yr - $185K/yr

5+ years exp

Science is a clinical stage technology company focused on addressing significant unmet medical needs in neuroscience. The Senior Regulatory Specialist will drive global regulatory strategies for medical devices and biologic products, guiding cross-functional teams through complex regulatory pathways to ensure innovative technology reaches patients safely and efficiently.

BiotechnologyMedicalNeuroscience

Hiring Manager

Tyler Lahti

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

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

Qualification

Regulatory strategy developmentFDA submissions expertiseEU MDR requirements knowledgeProject management skillsMedical device regulationsBiologics regulations knowledgeRegulatory certification (RAC)Analytical skillsLanguage proficiencyInterpersonal skillsCommunication skillsProblem-solving skillsTeam collaborationAttention to detail

Required

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)