RA Consultant (IVDs)

Kelly; New Zealand; On-site; NZD 120,000 - 180,000; Full time

Job summary

Kelly is seeking an experienced Regulatory Affairs Consultant (IVD) to drive regulatory strategy and FDA submissions for IVD assays, devices, and SaMD. You will guide clients through US, NZ, AU/NZ, and EU regulatory pathways with a focus on market access and product labeling.

The role requires strong writing, project management, and ability to interact with multidisciplinary teams across R&D, manufacturing, and leadership to navigate regulatory challenges.

Qualifications

• Bachelor’s degree or higher in Life Sciences or related field.
• 5+ years dedicated regulatory affairs experience in medical devices or IVD.
• Proven track record of successful US FDA submissions (510(k), De Novo, PMA, Q-Sub).
• Knowledge of FDA regulations for diagnostics (21 CFR Parts 809, 807, 812, 820/QMSR).
• Familiarity with Medsafe/WAND and AU/NZ regulatory environments.

Responsibilities

• Develop regulatory strategies and submissions for US FDA for IVDs.
• Author and assemble FDA submission packages including validation and labeling.
• Coordinate FDA interactions (Q-Sub, Pre-Sub meetings, day 76, response to information requests).
• Guide NZ Medsafe notifications and international market access strategies.

Skills

5+ years regulatory affairs

US FDA submissions

Technical writing

Communication

Self-motivation

Stakeholder engagement

Education

Bachelor’s degree or higher in Life Sciences

Job description

We are seeking an experienced Regulatory Affairs Consultant specializing in In Vitro Diagnostics (IVD) to support innovative life sciences and medtech clients across New Zealand and internationally.

In this role, you will lead regulatory strategy, author pre-market submissions, and guide clients through complex market access pathways—with a primary focus on the United States (FDA), alongside New Zealand (Medsafe) and key international jurisdictions (TGA, EU IVDR). You will serve as a subject‑matter expert for R&D, clinical, and leadership teams navigating the transition from bench to commercial market.

Key Responsibilities

1. US FDA Strategy & Submissions

• Develop comprehensive regulatory strategies and pathway assessments (510(k), De Novo, PMA, Q-Submissions, and CLIA waiver applications) specifically for IVD assays, instruments, and software (SaMD).
• Author, review, and assemble complete FDA submission packages, addressing analytical performance, clinical validation, software documentation, and labeling.
• Plan, lead, and coordinate formal interactions with the FDA (Q-Submissions, Pre-Sub meetings, Day 76 calls, and response to Additional Information requests).
• Stay current with FDA CDRH guidance documents, CLSI standards, and evolving FDA policies (including QMSR and LDT regulations).

2. IVD Technical & Clinical Documentation

• Review and interpret analytical validation protocols and reports (accuracy, precision, LoD/LoQ, linearity, analytical specificity, cross-reactivity, interfering substances).
• Guide clinical validation study design and evaluate clinical performance data in compliance with GCP and applicable regulations.
• Advise on IVD-specific risk management files in accordance with ISO 14971 and human factors/usability engineering requirements (IEC 62366).
• Review product labeling, Instructions for Use (IFU), and marketing materials for regulatory compliance.

3. New Zealand & Global Market Access

• Guide clients through New Zealand regulatory compliance, including Medsafe notifications via the WAND database and local code of practice standards.
• Support international expansion strategies, aligning FDA technical files with Australia (TGA inclusion) and Europe (EU IVDR 2017/746 technical documentation).
• Monitor global regulatory changes impacting the diagnostics sector and advise clients on gap assessments.

4. Quality Systems & Client Advisory

• Advise on Quality Management System (QMS) implementation and maintenance aligned with ISO 13485 and FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR).
• Function as a trusted advisor to multidisciplinary client teams (R&D, clinical affairs, manufacturing, executive leadership).
• Manage end-to-end consulting engagements: scoping, deliverables, timelines, and stakeholder communications.

Key Requirements

Experience & Technical Knowledge

• Bachelor’s degree or higher in Life Sciences, Molecular Biology, Biochemistry, Biomedical Engineering, or a related discipline.
• 5+ years of dedicated regulatory affairs experience within the medical device or IVD industry (consulting experience preferred).
• Proven track record of successful US FDA submissions for IVDs (demonstrated authorship and clearance of 510(k)s, De Novo requests, or Pre-Submissions).
• Working knowledge of FDA regulations applicable to diagnostics (21 CFR Parts 809, 807, 812, 820/QMSR) and relevant CLSI standards.
• Familiarity with the New Zealand Medsafe/WAND framework and the Australia/NZ regulatory environment.
• Technical Writing: Exceptional ability to synthesize complex scientific and clinical data into clear, persuasive regulatory arguments.
• Problem Solving: Aptitude for defining pragmatic regulatory strategies for novel biomarkers, technologies, or decentralized testing platforms.
• Communication: Confident stakeholder engagement with the ability to articulate regulatory risk to non-regulatory executives and investors.
• Self-Motivation: Ability to work autonomously, prioritize across multiple concurrent client projects, and deliver against fixed milestones.

Preferred Qualifications

• Regulatory Affairs Certification (RAC) from RAPS.
• Experience with digital health, AI/ML-enabled IVDs, or Software as a Medical Device (SaMD).
• Practical exposure to EU IVDR (2017/746) conformity assessments or TGA conformity assessments.