Regulatory Affairs Lead – Medical Devices & Software

Pascall Systems, Inc.; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Dental insurance

Health insurance

Paid time off

Job summary

PASCALL Systems is seeking a Regulatory Affairs professional in Cambridge, MA to drive regulatory strategy and coordinate FDA/CE submissions for our EEG-based medical device platform. You will work closely with product, clinical, and quality teams to ensure design controls, risk management, and labeling align with FDA expectations.

Ideal candidates bring 4–6 years in regulated medical devices, strong writing skills, and the ability to balance risk with business needs in a small company

Qualifications

• 4-6 years of regulatory affairs experience in medical devices, digital health, software as a medical device, clinical monitoring, or a related regulated environment.
• Experience supporting FDA submissions, ideally including 510(k) submissions for Class II medical devices. Experience with CE Mark/EU MDR is a strong plus
• Working knowledge of design controls, risk management, verification and validation, labeling, and change impact assessment.
• Strong writing skills and the ability to produce clear, audit-ready regulatory documentation.
• Practical judgment: ability to balance regulatory risk, patient safety, product value, and company priorities.

Responsibilities

• Support CEO on Regulatory Strategy Execution: work with our CEO to define and execute regulatory strategies for new features, product changes, indications, and future platform expansion.
• Support FDA and CE Mark Submissions: Prepare, coordinate, and maintain regulatory submissions and related documentation, including 510(k) materials and responses to agency questions.
• Maintain Regulatory Compliance: Ensure product development activities remain aligned with applicable FDA requirements, guidance, and standards, including IEC 62304, ISO 14971, ISO 13485, and related medical‑device expectations.
• Partner Across Product Development: Work with software, hardware, clinical, algorithm, and quality teams to review requirements, design changes, risk analyses, verification and validation plans, and labeling.
• Assess Product Changes: Evaluate software, hardware, algorithm, labeling, and workflow changes for regulatory impact and help determine submission requirements.
• Support Clinical and Customer‑Facing Work: Provide regulatory input for clinical evaluations, usability work, customer deployments, security reviews, and field feedback when regulatory implications arise.
• Improve Regulatory Processes: Build practical, scalable processes and templates that make regulatory work more efficient without sacrificing quality.
• Monitor Regulatory Landscape: Track relevant FDA guidance, standards, and industry practices for software as a medical device, clinical monitoring, AI/algorithm‑enabled devices, and interoperability.

Skills

Regulatory affairs

FDA submissions

CE Mark / EU MDR

Design controls

Risk management

Documentation

Stakeholder communication

Small-company environment

Education

Bachelor's degree

Job description

PASCALL Systems is seeking a Regulatory Affairs professional in Cambridge, MA to drive regulatory strategy and coordinate FDA/CE submissions for our EEG-based medical device platform. You will work closely with product, clinical, and quality teams to ensure design controls, risk management, and labeling align with FDA expectations.

Ideal candidates bring 4–6 years in regulated medical devices, strong writing skills, and the ability to balance risk with business needs in a small company