Senior Regulatory Specialist

Science Corporation•Alameda, CA

51d•$140,000 - $185,000

About The Position

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience's hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry. The Senior Regulatory Specialist will serve as the regulatory expert within our Quality and Regulatory Affairs team, where each team member brings both quality and regulatory knowledge but specializes in a specific domain. This role will drive global regulatory strategies for our medical device and biologic products, guide cross-functional teams through complex regulatory pathways, and ensure our innovative technology reaches patients safely and efficiently. While regulatory-focused, this position requires understanding of quality systems to effectively integrate regulatory requirements throughout the product lifecycle.

Requirements

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)

Nice To Haves

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

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.