Key Responsibilities and Required Skills for Regulatory Affairs Specialist — In Vitro Diagnostics (IVD)

🎯 Role Definition

The Regulatory Affairs Specialist — IVD is responsible for developing, executing, and maintaining regulatory strategies that enable timely market access for in vitro diagnostic products across global markets. This role combines technical writing, regulatory intelligence, cross-functional project leadership, and hands-on preparation of regulatory submissions (e.g., IVDR documentation, FDA 510(k)/De Novo dossiers) while ensuring ongoing compliance with ISO 13485, ISO 14971, and local regulations. The Specialist partners closely with R&D, Quality, Clinical, Manufacturing, and Commercial teams to translate product design and evidence into robust regulatory filings and post-market activities.

📈 Career Progression

Typical Career Path

Entry Point From:

Regulatory Affairs Associate or Coordinator (IVD or medical devices)
Quality Assurance Specialist with device/IVD experience
Clinical Affairs or Clinical Research Coordinator supporting diagnostics

Advancement To:

Senior Regulatory Affairs Specialist — IVD
Regulatory Affairs Manager (IVD or Medical Devices)
Head/Director of Regulatory Affairs or Global Regulatory Lead

Lateral Moves:

Quality Systems Manager (ISO 13485)
Clinical Affairs Manager (diagnostics)
Product Manager for IVD product lines

Core Responsibilities

Primary Functions

Develop, implement, and maintain comprehensive regulatory strategies for IVD products across multiple geographies (EU IVDR, US FDA, Canada, APAC, LATAM), ensuring alignment with business timelines and clinical/technical development plans.
Prepare, author, and assemble complete technical documentation and regulatory dossiers for IVDR conformity assessment routes, including EU Technical Documentation, UDI submissions, and Notified Body interactions.
Lead the preparation and submission of US regulatory filings such as 510(k), De Novo requests, pre-submission packages, and responses to FDA deficiency letters, coordinating subject-matter experts to meet submission requirements.
Create and maintain clinical evaluation plans (CEP), clinical evaluation reports (CER), and performance evaluation documentation in accordance with IVDR and MEDDEV/ MDCG guidance for IVD devices.
Generate, review, and maintain device labeling, Instructions for Use (IFU), package inserts, and advertising/promotional materials to ensure regulatory compliance and claims substantiation across markets.
Develop and maintain regulatory compliance matrices and product regulatory status trackers, ensuring all registrations, renewals, and post-approval obligations are met on schedule.
Conduct regulatory gap analyses and risk-based assessments of product changes, design updates, and component substitutions, defining regulatory pathways and change control impacts.
Maintain up-to-date regulatory intelligence by monitoring global regulatory changes (IVDR guidance documents, FDA policy updates, international standards) and recommend actions to leadership and cross-functional teams.
Coordinate and support internal and external audits, Notified Body assessments, and FDA inspections by preparing evidence packages, organizing responses, and driving corrective/preventive actions (CAPAs) as needed.
Lead labeling negotiations and submissions for marketing authorization changes, ensuring translations, local regulatory requirements, and cultural adaptations are addressed for international markets.
Support product lifecycle management by preparing and submitting amendments, supplements, and renewals for registrations, CE marking updates, and US market changes.
Collaborate with R&D and Quality teams to ensure design controls, traceability, and device master records meet regulatory expectations and that regulatory requirements are incorporated into product specifications.
Provide regulatory input to risk management files, ensuring ISO 14971 risk controls and mitigations are reflected in submissions and clinical/performance documentation.
Evaluate and qualify suppliers and contract manufacturers from a regulatory perspective, ensuring supplier documentation supports regulatory submissions and post-market surveillance requirements.
Prepare regulatory portions of grant applications, partner/vendor agreements, and clinical study documents, ensuring compliance with local regulatory and ethical requirements for device studies.
Author regulatory policies, procedures, and work instructions to support a compliant regulatory affairs function and ensure consistent execution across teams.
Manage cross-functional regulatory project timelines, stakeholder communications, and submission checklists to deliver on-time regulatory deliverables in fast-paced development programs.
Draft and review responses to regulatory authority questions and deficiency reports with robust evidence-based justifications and coordinate internal reviews before submission.
Support commercialization activities by advising on regulatory implications of marketing claims, promotions, and sales training content to prevent non-compliant communications.
Lead post-market surveillance (PMS) and vigilance activities for IVD products, including complaint triage, trend analysis, periodic safety update reports (PSURs), and reportable event submissions to regulatory authorities.
Facilitate product transfers, manufacturing site changes, and packaging/site changes by preparing regulatory change notifications and ensuring uninterrupted market supply.
Provide training and mentorship to junior regulatory staff on dossier compilation, regulatory intelligence, and submission best practices to build team capability.

Secondary Functions

Contribute to regulatory input for cybersecurity, software as a medical device (SaMD) assessments, and validation of software components of IVD systems.
Participate in commercial and market access planning to ensure regulatory timelines are integrated into product launch roadmaps.
Support integration activities during mergers, acquisitions, or licensing deals to align regulatory files and product portfolios.
Assist in preparing regulatory budgets and resourcing plans for product registration activities and external consultant engagement.
Serve as a regulatory liaison to external partners, contract research organizations (CROs), and Notified Bodies to ensure clear expectations and timely delivery of third-party deliverables.
Provide ad-hoc regulatory support for promotional material review, investigator brochures, and clinical trial regulatory submissions.
Support implementation and continuous improvement of regulatory tracking tools and electronic document management systems (eDMS) to optimize dossier assembly and retrieval.
Participate in cross-functional risk workshops and design reviews to ensure emerging regulatory gaps are mitigated early in product development.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of EU IVDR requirements (Regulation (EU) 2017/746), including conformity assessment routes, classification rules, and clinical/performance evidence expectations.
Practical experience preparing US FDA submissions (510(k), De Novo, pre-sub, and responses to Q-Sub/AI/other FDA communications).
Proven ability to author and compile Technical Files / Design Dossiers, clinical evaluation reports (CER), performance evaluation reports, and regulatory summaries for IVDs.
Strong understanding of Quality Management Systems for medical devices and IVDs, particularly ISO 13485 requirements and interaction with regulatory submissions.
Familiarity with risk management per ISO 14971 and ability to integrate risk analyses into regulatory documentation and labeling.
Experience with post-market surveillance (PMS), vigilance reporting, trend analysis, and periodic safety/clinical update reporting for IVD products.
Competence in preparing and maintaining Unique Device Identification (UDI) submissions and device registration databases for global markets.
Working knowledge of laboratory standards and clinical performance study design for diagnostics, including sensitivity/specificity, analytical validation, and clinical validation protocols.
Skill in regulatory intelligence tools and sources, and demonstrated ability to translate guidance documents into actionable regulatory strategy.
Proficiency with electronic document management systems (eDMS), submission publishing tools, and MS Office suite for complex document assembly and version control.
Experience with product labeling creation and regulatory review processes, ensuring claims are supported by evidence and compliant across jurisdictions.
Familiarity with software/firmware validation and requirements for software-driven IVDs, including SaMD regulatory considerations.

Soft Skills

Strong written communication skills with the ability to produce clear, structured regulatory documents, submission narratives, and responses to authorities.
Excellent stakeholder management and cross-functional collaboration skills; able to influence R&D, Quality, Clinical, and Commercial teams.
Detail-oriented with strong organizational skills; capable of managing multiple submission tracks and timelines simultaneously.
Analytical thinker with the ability to interpret regulations, identify risks, and propose pragmatic, business-aligned solutions.
Proactive mindset, self-starter attitude, and ability to work independently in a fast-paced, evolving regulatory landscape.
Project management skills with experience coordinating multi-stakeholder deliverables and meeting regulatory milestones.
Adaptability and resilience when navigating regulatory uncertainty and changing global requirements.
Mentoring and team development abilities to grow junior regulatory talent and share best practices.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Pharmacy, or related scientific/technical discipline.

Preferred Education:

Master’s degree or advanced degree in Regulatory Science, Clinical Research, Biomedical Engineering, or related field.
Professional certifications such as RAC (Regulatory Affairs Certification) or equivalent regulatory training are advantageous.

Relevant Fields of Study:

Biomedical Engineering
Biology, Molecular Biology, or Biotechnology
Pharmacy or Clinical Laboratory Science
Regulatory Science or Public Health

Experience Requirements

Typical Experience Range: 2–5 years of regulatory affairs experience, with at least 1–2 years focused on in vitro diagnostics (IVD) or medical devices.

Preferred: 3–7 years of progressive regulatory experience with demonstrated ownership of IVDR documentation and at least one US FDA submission (e.g., 510(k)/De Novo), experience interacting with Notified Bodies or regulatory authorities, and hands-on involvement in clinical performance evaluation for diagnostics.