Manager, Quality and Regulatory Affairs

Position Title: Manager, Quality and Regulatory Affairs

Department: Quality and Regulatory Affairs

Location: Woodland Hills, CA

Employment Type: Full-Time

Position Overview 

The Manager, Quality and Regulatory Affairs will serve as the primary owner of Perin Health’s Quality Management System (QMS) and regulatory compliance strategy. This is a high-impact, hands-on role responsible for maintaining and continuously improving quality systems, ensuring ongoing FDA compliance, managing post-market surveillance activities, and supporting current and future regulatory submissions. The ideal candidate thrives in a startup environment, is comfortable wearing multiple hats, and brings deep experience in both quality management and regulatory affairs for Class II medical devices with embedded software and SaMD components. 

Key Responsibilities 
 

•    Own and maintain the company’s ISO 13485-compliant QMS, including all SOPs, work instructions, policies, and quality records.

•    Lead design transfer activities, ensuring smooth transition of the Perin Health Patch and software platform from development to production, including process validation, manufacturing documentation, and acceptance criteria.

•    Develop and execute ongoing quality testing programs for production devices, including incoming inspection, in-process testing, and final release testing protocols.

•    Manage document control processes, ensuring all quality and regulatory documentation is current, properly reviewed, approved, and accessible.

•    Conduct and coordinate internal audits per ISO 19011 to monitor QMS effectiveness; drive continuous improvement based on audit findings, management reviews, and quality metrics.

•    Lead management review meetings, preparing quality data analysis, trend reports, and action items for executive leadership.

•    Develop and deliver quality system training programs for cross-functional team members, ensuring organization-wide regulatory awareness and compliance.

Post-Market Surveillance & Vigilance 

•    Establish and manage the post-market surveillance (PMS) system, including complaint handling, device return evaluation, and trend analysis.

•    Own the Corrective and Preventive Action (CAPA) system—initiate, investigate, and drive CAPAs to closure with root cause analysis and effectiveness verification.

•    Manage Medical Device Reporting (MDR) to the FDA, including evaluation of reportable events, timely submission of adverse event reports, and maintenance of the MDR complaint file.

•    Develop and maintain post-market surveillance plans and periodic safety update reports as required.

•    Coordinate field safety corrective actions and product recalls if necessary, including communications with distributors, healthcare providers, and regulatory authorities.

Regulatory Affairs 

•    Serve as the primary point of contact for all FDA communications, including responses to deficiency letters, interactive review requests, and general correspondence.

•    Support the preparation and submission of Q-Submissions (Pre-Submissions) to the FDA for planned algorithm enhancements and hardware modifications.

•    Prepare letters to file for software and hardware changes to existing cleared devices, maintaining thorough regulatory rationale and supporting documentation.

•    Provide regulatory review and guidance for ongoing and planned clinical studies, including protocol review, regulatory impact assessment, and study documentation.

•    Support future 510(k), De Novo, or other premarket submissions for new algorithms, indications, or hardware changes, including predicate device analysis, substantial equivalence arguments, and performance data compilation.

•    Monitor and communicate changes in FDA regulations, guidance documents, and industry standards relevant to RPM devices, wearables, SaMD, and AI/ML-based medical devices.

•    Maintain device listings, establishment registrations, and Unique Device Identification (UDI) records with the FDA.

IRB & Clinical Study Support 

•    Support Institutional Review Board (IRB) submissions for clinical validation studies, including initial applications, amendments, continuing reviews, and adverse event reporting.

•    Ensure clinical studies are conducted in compliance with applicable regulations (21 CFR Parts 50, 56, and 812 as relevant), Good Clinical Practice (GCP), and institutional requirements.

•    Maintain clinical study regulatory binders and essential documents for audit readiness.

Additional Responsibilities 

•    Working collaboratively with Hardware and Software development teams.

•    Manage supplier quality, including qualification, evaluation, and monitoring of contract manufacturers, component suppliers, and third-party testing laboratories.

•    Lead FDA inspection readiness activities and serve as the company representative during FDA facility inspections and ISO 13485 certification audits.

•    Own and maintain the company’s risk management file per ISO 14971, ensuring the risk management process is integrated throughout the product lifecycle, including post-production information feedback.

•    Manage labeling compliance for the device and software, including Instructions for Use (IFU), packaging labels, and promotional material review for regulatory accuracy.

•    Support the development of regulatory strategy for international markets (e.g., EU MDR/CE marking, Health Canada) as the company evaluates global expansion.

•    Collaborate with business development and clinical teams to ensure marketing claims and CPT code-related documentation (RPM, RTM, CCM) are consistent with regulatory clearances.

•    Evaluate and implement eQMS software tools to improve efficiency and scalability of quality and regulatory operations.

Qualifications 
Required 

•    Bachelor’s degree in biomedical engineering, life sciences, regulatory science, or a related technical discipline.

•    5 years of experience in quality assurance and/or regulatory affairs for FDA-regulated Class II medical devices, with direct experience in 510(k) submissions.

•    Demonstrated hands-on experience managing an ISO 13485-compliant QMS, including document control, CAPA, complaint handling, internal audits, and management review.

•    Experience with FDA post-market requirements, including Medical Device Reporting (MDR), post-market surveillance, and field corrective actions.

•    Familiarity with ISO 14971 (risk management) and the ability to maintain and update risk management files throughout the product lifecycle.

•    Experience communicating directly with the FDA, including Q-Submissions, deficiency responses, and inspection support.

•    Excellent technical writing skills with the ability to produce clear, well-organized regulatory submissions and quality documentation.

•    Self-directed and comfortable operating in a startup environment with minimal oversight.

Preferred 

•  RAC (Regulatory Affairs Certification) from RAPS.  

•  Experience with wearable medical devices, remote patient monitoring systems, or physiological signal monitoring technologies (ECG, PPG, bioimpedance).

•  Experience with IRB submissions, clinical study regulatory compliance, and GCP requirements.

•  Familiarity with AI/ML-based SaMD regulatory frameworks, including FDA’s Predetermined Change Control Plan (PCCP) guidance.

•  Experience with IEC 60601-1 (electrical safety) and IEC 62366 (usability engineering) standards.

•  Experience with EU MDR (2017/745) and international regulatory submissions.

•  Hands-on experience with design controls and design transfer for combination hardware/software medical devices.

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Potawatomi Federal Solutions is an equal opportunity employer. Potawatomi Federal Solutions LLC does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, marital status or any other characteristic protected by law.