Head of Quality and Regulatory Affairs

About Panabistics Corp.

Panabistics Corp. is a leading global regulatory and quality consulting firm specializing in medical devices and digital health technologies. We provide expert services to clients ranging from early-stage startups to large multinational corporations. Our services cover the full product lifecycle, including regulatory strategy, submissions, QMS implementation, product compliance, and post-market surveillance.

Job Description

We are seeking an experienced and highly motivated Senior Regulatory & Quality Consultant to support a wide range of projects involving FDA, EU MDR, UKCA, MDSAP, and global regulatory pathways. The ideal candidate will have deep technical and regulatory knowledge, including hands-on experience with 510(k), PMA, CE marking, IDEs, AI/ML-based SaMD, and international standards.

Key Responsibilities

• Consult with clients, from startups to major corporations, secure marketing authorizations for active and nonactive products across global markets, including FDA, EU MDR, and UKCA approvals.
• Collaborate with cross-functional product development teams to provide QA and RA input throughout the design and development lifecycle, and ensure timely risk mitigation and regulatory alignment.
• Review and ensure conformity with FDA 21 CFR Part 800.10 to 800.75 and EU MDR Articles 1 to 6, incorporate labeling and misbranding compliance.
• Develop and maintain labeling and IFU strategies per 21 CFR Part 801.1 to 801.437 and EU MDR Articles 10, 18, and 19, and Annex III.
• Support Medical Device Reports (MDRs) submissions aligned with 21 CFR Part 803.1 to 803.58, EU MDR Article 87 & 88, and Annex III.
• Develop recall readiness strategies in compliance with 21 CFR Part 806.1 to 806.40, and EU MDR Articles 89, 92, and Annex III.
• Support eSTAR submissions.
• Prepare, submit, and obtain FDA 510(k), IDE, and PMA clearances and DeNovo petitions.
• Managed establishment registration under 21 CFR Part 807.20 – 807.25.
• Prepare Q-subs, and chair FDA pre-submission and submissions meetings.
• Lead CAPA lifecycle activities under 21 CFR Part 820.100 and ISO 13485; execute change control and NC processes.
• Conduct mock recalls aligned with 21 CFR Part 810 and manage IDE submissions under Part 812 and PMA under Part 814.
• Direct device tracking per 21 CFR Part 821 and postmarket surveillance under Part 822.
• Support UDI implementation under Part 830 and product classification under Part 860 and 861.
• Implement QMS for 15 clients, reduce audit findings; achieve MDSAP certifications.
• Support EU MDR conformity assessments and CERs in compliance with Annexes II & III.
• Execute internal audits and inspection readiness per ISO 13485, MDSAP, and 21 CFR 820.
• Champion human factors engineering and usability per IEC 62366; created SOPs and testing strategies.
• Develop Clinical Evaluation Plans and Reports.
• Consult on electro-technical safety (IEC 60601-1), biocompatibility (ISO 10993), and risk management (ISO 14971).
• Secure NRTL and CB Scheme certifications.
• Direct global regulatory strategy; author regulatory strategy documents across all device classes.
• Act as PRRC under EU MDR Article 15 for clients.
• Lead regulatory lifecycle for AI/ML medical devices, including real-world evidence and model updates.
• Execute AI-based SaMD regulatory strategies compliant with FDA, MDR, ISO 13485, IEC 62304, and IMDRF.
• Design post-market monitoring frameworks for AI/ML devices, including adverse event and model drift protocols.
• Integrate AI lifecycle into QMS and risk management aligned with ISO/IEC 42001 and ISO 14971.
• Support clients in preparing for EU Data Act (2024/1869) obligations and data-sharing readiness.

Qualifications

• Bachelor’s Degree in STEM (Science, Technology, Engineering, and Math)
• 10+ years of demonstrated experience in medical device quality, product compliance, and regulatory affairs.
• Ability to travel to clients’ sites if needed.

Core Competencies

• 21 CFR Chapter I, Subchapter H, Parts 800 to 898
• Quality Management Training QMS Auditing
• Technical Documentation Assessment
• (EU) 2017/745 Medical Device Regulation
• ISO 13485
• Risk Assessment
• EU MDR Technical Documentation
• Medical Devices Quality Management Systems
• Health Canada MDL and MDEL experience.

To Apply

This is a fully remote position open to applicants worldwide. Please submit your CV. Open to independent consultants with expertise in medical device QA/RA consulting.

Job Types: Full-time, Part-time, Fixed term contract, Freelance

Experience:

• Medical Device Quality Management System: 10 years (preferred)
• Medical Device Product Safety Compliance: 10 years (preferred)
• Medical Device Regulatory Affairs: 10 years (preferred)

Work Location: Remote