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Regulatory Specialist

Science Corporation· Quality and Regulatory Affairs
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Alameda, CA$140k - $185kfull-timePosted 6mo ago

About the role

Senior Regulatory Specialist leading global regulatory strategies for medical device and biologic products, guiding cross-functional teams through complex regulatory pathways while integrating regulatory requirements throughout the product lifecycle.

Responsibilities

  • Develop and execute strategic regulatory plans for medical devices and combination products 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 to meet timelines and business objectives.
  • Serve as liaison with regulatory authorities (FDA, Notified Bodies, and other global health authorities).
  • Lead rapid response efforts to regulatory agency communications, draft responses within tight timelines.
  • Manage and update risk management files per 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).
  • Manage certificates, authorizations, and device registrations.
  • Architect and maintain regulatory watch systems for global regulations.
  • Monitor and interpret evolving regulations, translating into actionable guidance for cross-functional teams.
  • Shape and maintain regulatory components of the QMS in line with ISO 13485, MDR 2017/745, and FDA QSR.
  • Drive process and system improvements to optimize submission outcomes.
  • Design templates, tools, and training materials to scale regulatory knowledge.
  • Guide product development teams on regulatory requirements from concept through commercialization.
  • Participate in strategic planning and design reviews as regulatory/quality SME.
  • Mentor team members on regulatory strategy and submission preparation.
  • Support internal audits and regulatory inspections; back up for quality-focused team members.
  • Coordinate regulatory aspects of clinical trials including authority notifications and approvals.
  • Collaborate with quality colleagues to integrate regulatory requirements into manufacturing and post-market processes.

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)
  • Strong knowledge of global medical device regulations and ability to 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 cross-functional collaboration and influence
  • Demonstrated success managing parallel projects in a fast-paced environment
  • Strong analytical and problem-solving capabilities with attention to detail
  • Ability to travel (domestic and international)

Skills

Required:Regulatory strategyRegulatory submissionsQuality Management System

Benefits

  • Competitive salary and equity
  • Medical, dental, vision and life insurance
  • Flexible vacation and company-paid holidays
  • Healthy meals and snacks for non-remote employees
  • Paid parental, jury duty, bereavement, family care and medical leave
  • Dependent Care Flexible Spending Account, subsidized by Science
  • Flexible Spending Account
  • 401(k)
Last updated Oct 23, 2026. Interested? Apply on the company site.
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About Science Corporation

Transcend the limits of biology

Science Corporation is a clinical-stage medical technology company.

medical technologybrain-computer interfaceneural interfacesvision restorationneurotechnology
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