Director, Global Regulatory Affairs IVD

RQM+; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

A leading MedTech consulting firm is seeking a Vice President for IVD Global Regulatory Affairs to oversee regulatory and clinical strategies for IVD products across the US and EU. This senior role requires strong expertise in FDA and EU IVDR regulations, extensive leadership experience, and the ability to contribute to innovative regulatory solutions. The candidate will serve as the main technical authority for IVDs, lead complex client engagements, and mentor technical staff. Competitive compensation and professional growth opportunities are offered.

Qualifications

• Minimum 10 years’ relevant experience in clinical, technical, or regulatory fields.
• Minimum 5 years’ experience in IVDs design or clinical application.
• Extensive knowledge of In Vitro Diagnostic Regulations, particularly EU MDR/IVDR.

Responsibilities

• Serve as the technical authority for IVDs across US and EU markets.
• Lead complex IVD engagements for FDA and EU IVDR approval.
• Mentor and coach IVD consultants and project teams.

Skills

Technical leadership

Regulatory expertise

Clinical trials knowledge

Cross-functional collaboration

Business acumen

Education

Advanced degree in relevant sciences

University degree in relevant sciences

Job description

4 days ago Be among the first 25 applicants

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA‑recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life‑changing technologies to patients — faster, safer, better.

We don’t make MedTech. We make MedTech happen.

Job Summary

The Vice President, IVD Global Regulatory Affairs is a senior technical leader responsible for both strategic oversight and direct client delivery of regulatory, quality, and clinical solutions for IVD products across the United States and European Union. This role is responsible for monitoring market, customer, and competitor trends in the medical device and in vitro diagnostic and regulatory consulting industries and leveraging these insights to help drive client success as well as RQM+ business expansion, technical quality improvement, commercialization, and marketing efforts.

This role serves as the primary technical authority for IVDs within RQM+, providing deep expertise in FDA and EU IVDR requirements while remaining actively billable on complex, high‑risk, and first‑of‑kind client engagements. The ideal candidate is a hands‑on player‑coach with extensive execution experience who can lead teams, shape service offerings, and represent RQM+ as an industry thought leader.

Primary Responsibilities

• Serve as the technical authority for IVDs across US and EU markets, including regulated IVDs, Laboratory Developed Tests (LDTs), and Companion Diagnostics
• Lead and execute complex, high‑risk, or novel IVD engagements targeting FDA and EU IVDR approval
• Perform direct, billable client work on advanced regulatory, clinical, and performance evaluation programs
• Develop and execute US and EU regulatory strategies, performance evaluation plans and reports (PEPs/PERs), and clinical evidence approaches
• Act as senior technical reviewer for critical submission deliverables
• Support and lead FDA interactions and EU Notified Body engagements
• Translate regulatory changes, guidance, and policy updates into practical, actionable guidance for clients and internal teams

Solution Development & Business Support

• Define, evolve, and standardize IVD technical solution offerings aligned with FDA and EU IVDR expectations
• Shape technical approaches, scope, and resourcing for proposals and statements of work
• Participate in technical discovery discussions and senior‑level, client‑facing engagements
• Establish technical standards, templates, tools, and best practices across IVD programs

People Leadership & Capability Building

• Mentor, coach, and technically guide IVD consultants and project teams
• Support hiring, onboarding, and professional development of IVD technical staff
• Contribute subject matter expertise to RQM+ technical training programs and learning initiatives

Industry Leadership & Thought Leadership

• Act as a visible and credible representative of RQM+ within the IVD and medical device regulatory community
• Speak on behalf of RQM+ at key industry conferences, congresses, and regulatory forums
• Develop and deliver webinars, white papers, blogs, and conference presentations
• Participate in industry committees and working groups relevant to IVD regulation

Strategic Intelligence & Innovation

• Provide proactive technical and regulatory insight to the SVP, Intelligence and Innovation and RQM+ Executive Team on industry trends, regulatory changes, market opportunities, and business risks
• Monitor competitor activity and evolving regulatory landscapes to identify threats and growth opportunities
• Guide the development of intelligence reports supporting RQM+ business expansion and commercialization strategies
• Identify opportunities for technical quality improvements and regulatory solution innovation
• Partner with Division leaders to support marketing strategies and positioning of IVD services
• Leads efforts in planning, execution, and interpretation of clinical research requirements.
• Oversees and approves implementation and delivery of regulatory strategies of clinical protocols,
• Oversees development, implementation and maintenance of appropriate standard operating procedures and policies to ensure compliance with regulations, guidelines and standards related to clinical research studies.
• Stays current with market, clinical, regulatory, and quality developments.
• Routinely interacts with and reports to executive‑level management on progress of Regulatory Affairs programs and studies.
• Collaborates with Regulatory and Quality Affairs and R&D to transition preclinical studies to clinical Regulatory Affairs for product development and to develop clinical studies to support regulatory approvals across multiple geographies.
• Ensures Regulatory Affairs is effectively represented in new product development activities.
• Develop and maintain Regulatory Strategies to release and maintain product in accordance with the Standards and Regulatory requirements.
• Interface with regulatory agencies such as FDA and Notified Bodies (NB).
• Provide RA leadership/support to New Product Development (NPD) teams.
• Provide strategic direction on labeling, regulations, and standards.
• Support the regulatory aspects of medical devices and/or diagnostic devices across a range of classifications.
• Collaborate cross‑functionally with R&D, manufacturing, medical, clinical, non‑clinical and marketing to incorporate their reports into submissions.
• Create, edit, review, and maintain regulatory submissions to support country specific marketing approval. Ex: Technical Documentation, Design Dossiers, 510(k), IDE, PMA, de novo, etc.
• Submit and/or review PMAs/supplements/30‑day notices.
• Obtain approvals for new medical devices, and/or SW and/or diagnostics and determine regulatory impact of design/process changes.
• Maintain product registration and review changes and registration updates as required to either regulators or NBs.
• Develop, maintain, review product labels, Instructions for Use (IFU) and any associated marketing material for compliance with applicable regulations and technical standards.
• Participate in strategy development for reimbursement.
• Perform gap assessments and propose remediation for regulatory submissions including technical files to EU MDR and/or IVDR.
• Support International Registration Requests and coordinate device change communication to regulatory agencies across the globe as necessary.
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions.
• Provide acquisition due diligence and integration.
• Review and provide input on clinical trials required for strategy development.

Education/Work Experience

• A university degree or equivalent qualification in relevant sciences such as: Chemistry, Biochemistry, Biology, Microbiology, Genetics, Biotechnology, Biomedical Sciences required
• Advanced degree preferred (MS, PhD or equivalent experience) in a relevant scientific discipline required (e.g., Chemistry, Biochemistry, Biology, Microbiology, Genetics, Biotechnology, Biomedical Sciences).
• Minimum 10 years’ relevant postgraduate clinical, technical, regulatory, or related experience, required; of which a minimum 5 years in the design or clinical application of IVDs (preferred)
• Minimum 5 years’ experience in a technical or regulatory leadership role relevant to the in‑vitro diagnostics industry required.

Requirements

• Experience of innovative technologies (eg NGS, personalized medicine, molecular diagnostics, etc) highly desirable.
• Previous experience in a regulatory body within target markets (US, EU, etc.) desirable/preferred.
• Extensive knowledge of In Vitro Diagnostic Regulations (EU MDR/IVDR) and/or FDA Regulations required.
• Examples of how your work has had a positive impact on and/or advanced the in vitro diagnostics industry desirable.
• Existing established network of decision‑makers within the regulatory and in vitro diagnostic industries desirable.
• Ability to collaborate with cross‑functional teams to produce high‑quality work and recommendations.
• Innovation Management: ability to bring creative ideas of others to market and has good judgment about which ideas/suggestions will benefit the company.
• Can distill large amounts of clinical, regulatory, and market data; interpret and translate data into insights and recommendations.
• Ability to educate and motivate others through targeted content, sound facilitation and coaching skills, and engaging approaches.
• Strong Business Acumen, with the ability to think strategically and respond appropriately to leadership, customer, and employee needs.
• Demonstrated, hands‑on experience authoring and executing US and EU IVD regulatory deliverables.
• Deep working knowledge of FDA IVD regulations and EU IVDR requirements.
• Experience supporting FDA meetings and EU Notified Body interactions.
• Experience with Companion Diagnostics, LDTs, and clinical trial assays.
• Exposure to innovative technologies such as NGS, molecular diagnostics, and personalized medicine.
• Prior consulting, CRO, or regulatory body experience (FDA, EU authority, etc.)
• Established professional network within the IVD and regulatory community.
• Demonstrated examples of contributing to or advancing the IVD industry.

Supervisory Responsibilities

This position may have supervisory responsibilities.

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