Senior Regulatory Affairs Specialist

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

Position Summary

PASCALL is a growing multidisciplinary medical device company building an FDA-cleared, EEG-based brain state monitoring platform — a wearable EEG sensor paired with an Android tablet application — now in active clinical use. As our platform matures, we are hiring a Regulatory Affairs professional to help guide our product, quality, and clinical plans through the regulatory pathways that support safe, effective, and compliant medical device development.

This is a hands‑on role based in Cambridge, working closely with our CEO, regulatory consultants, quality assurance and product teams. You will help translate product strategy into regulatory strategy, prepare and maintain regulatory submissions and documentation, support design‑control and risk‑management activities, and ensure that our evolving platform remains aligned with FDA expectations and applicable international standards.

Because the team is small and the roadmap is still being written, this role requires both regulatory rigor and practical judgment. We are looking for someone who can operate independently, clarify ambiguity, and help the company make smart, risk‑based decisions that support patient safety, business needs, and long‑term product growth.

Responsibilities & Opportunities

• 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.

Qualifications

Education

• Bachelor's degree in life sciences, engineering, regulatory affairs, biomedical engineering, or a related field — or equivalent professional experience.

Experience and Skills

• 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.

• Familiarity with FDA QSR / 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.

• 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.

• Comfort working in a small‑company environment where priorities evolve and ownership spans strategy, execution, and process improvement.

• Clear communicator who can work effectively with technical, clinical, quality, and executive stakeholders.

• High attention to detail and strong organizational habits for maintaining submission files, regulatory history, and decision records.

Technical Background (Preferred)

• Experience with software‑driven or connected medical devices.

• Familiarity with EEG, anesthesia, physiological monitoring, neuromonitoring, or hospital‑based clinical technologies.

• Exposure to AI/ML‑enabled medical device development, algorithm validation, or data‑driven clinical products.

• Experience reviewing cybersecurity, interoperability, or hospital IT considerations from a regulatory perspective.

• RAC certification or formal regulatory affairs training.

About PASCALL Systems

PASCALL is a Cambridge‑based medical device company focused on advancing neuroscience‑based personalized anesthesia monitoring. Our team includes leading academic and clinical experts from MIT, Harvard, Stanford, and Massachusetts General Hospital.

We achieved ISO 13485 certification for medical device design and development and received FDA 510(k) clearance for our platform system in 2022 and 2026 (upgraded sensor). We are now building the next generation of EEG‑based brain state algorithms to improve anesthesia care and patient outcomes worldwide.

Our vision is to bring personalized, science‑based anesthesia care to all patients.

Benefits

• Dental insurance

• Health insurance

• Paid time off

Work Location: Hybrid remote in Cambridge, MA 02139