Regulatory Affairs and Quality Assurance Manager

Who we are:

NeuroSync is a mission-driven, growth-stage Brain Health company revolutionizing care for the 1 in 4 people affected by conditions like traumatic brain injury (TBI), ADHD, and dizziness. Powered by proprietary diagnostic and brain performance platforms, cutting-edge AI, and advanced analytics, we’re redefining how brain health is measured, monitored, and improved—at scale. With breakthrough technology and a passionate team, NeuroSync is poised to lead one of the most important transformations in modern healthcare.

About the Role:

NeuroSync is actively seeking a Regulatory Affairs and Quality Manager to own NeuroSync’s regulatory strategy and day-to-day execution for our Class II medical device and software-enabled platforms. You will drive submissions and changes, guide claims and labeling, product roadmaps, oversee complaint/MDR decisions and CAPA, serve as the primary liaison with FDA and other authorities and partner closely with Manufacturing to ensure robust documentation, production quality and product release. This is a hands-on role at a fast-moving company: you’ll build lightweight processes that scale, while rolling up your sleeves to get filings over the finish line. As a small, fast-moving team, we’re looking for someone eager to wear multiple hats and jump into adjacent work whenever needed.

Key Responsibilities:

• Own U.S. regulatory maintenance for Class II devices: registration/listing, UDI/GUDID, and change control.
• Lead regulatory change assessments (letter-to-file vs. Special 510(k)); plan, author, and submit high-quality filings and responses.
• Prepare and run FDA interactions as needed (Q-subs/pre-subs), including meeting packages, minutes, and follow-ups.
• Govern claims & labeling: review website, marketing, IFU/labels, and sales collateral to align with cleared indications and wellness/medical boundaries.
• Partner on design control with R&D/Clinical: risk management (ISO 14971), usability (IEC 62366), SaMD lifecycle (IEC 62304), and software/cybersecurity change documentation.
• Maintain technical files (DHF/DMR/DHR), traceability, and release documentation with strong document control.
• Own day-to-day QMS upkeep (ISO 13485; 21 CFR 820/QMSR): revise SOPs/WIs, deliver training, and ensure procedural compliance.
• Manage post-market surveillance: complaint intake/investigation, MDR decisions and eMDR submissions (21 CFR 803), corrections/removals (806), and trend reporting.
• Run CAPA/NCR processes end-to-end, from root cause through effectiveness checks; drive timely closure and prevention.
• Support manufacturing quality: define incoming/in-process/final inspection plans, review device history records, support equipment calibration/maintenance, and assist with IQ/OQ/PQ basics.RA/QA Manager
• Review and approve engineering changes (ECOs); ensure appropriate verification/validation and documentation before release.
• Audit & inspection readiness: plan and conduct internal audits, support supplier audits, and host regulators/registrars; coordinate responses and follow-up actions.
• Own compliance metrics & reporting: track KPIs (complaints, CAPA cycle time, defects/FPY), prepare Management Review inputs, and communicate risk/priority.
• Enable cross-functional teams: coach Marketing/Sales on compliant claims, partner with Customer Support on field issues, and provide RA/QA gates for the product roadmap.

Skills & Qualifications:

• 2 years in medical device Regulatory Affairs and/or Quality with hands-on U.S. Class II experience.
• Bachelor’s in engineering, life sciences, or related field.
• Proven work on 510(k) maintenance/changes (letters-to-file), registration/listing, and UDI/GUDID.
• Practical ownership of postmarket: complaints, MDR (21 CFR 803) decisions/submissions, and 806 corrections/removals.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and the QMSR transition from 21 CFR 820.
• Experience running CAPA/NCR end-to-end and supporting audits/inspections.
• Strong claims/labeling review skill; comfortable drawing wellness vs. medical boundaries.
• Excellent technical writing, organization, and cross-functional communication; able to operate as the day-to-day RA/QA lead.
• Comfortable on-site and virtual collaboration with other departments.

Preferred (Nice to have):

• Direct contribution to pre-subs/Q-subs and agency meetings.
• SaMD/software change control experience (62304 artifacts, cybersecurity documentation).
• Building or refining lean SOPs/WIs, DHF/DMR/DHR, and document control systems (eQMS experience a plus).
• Statistics for quality trending (e.g., basic SPC, defect/FPY, CAPA effectiveness metrics).
• Certifications: RAC, ASQ CQE, ISO 13485 Internal Auditor.
• Background in neuro/vestibular/diagnostics or connected devices

Job Type: Full-time

Schedule:

• Monday to Friday

Ability to Commute:

• Holliston, MA 01746 (Required)

Work Location: In person

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance