Job Title
Regulatory Affairs Lead – Market Access (IVD & Medical Devices)
Work Schedule
Standard (Monday–Friday)
Work Mode
Office-Based
Company
Thermo Fisher Scientific
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, dedicated to enabling customers to make the world healthier, cleaner, and safer. The organization develops and delivers innovative solutions across life sciences, diagnostics, and healthcare, supporting global regulatory, clinical, and manufacturing operations across multiple regions.
For more information, visit: Thermo Fisher Scientific
Job Summary
We are seeking an experienced Regulatory Affairs Lead – Market Access to drive global regulatory strategy and execution for In Vitro Diagnostics (IVD) and Medical Device product portfolios.
The role is responsible for leading complex regulatory submissions across global markets, defining regulatory pathways, ensuring compliance with international regulations, and enabling successful product approvals and market access.
This position also involves mentoring team members and collaborating with cross-functional stakeholders including R&D, Quality, Manufacturing, and global regulatory authorities.
Key Responsibilities
Global Regulatory Strategy & Leadership
Lead development and execution of global regulatory strategies for product registrations, renewals, and change controls.
Define regulatory pathways for IVD and Medical Device portfolios across global markets.
Provide strategic input to ensure successful market access worldwide.
Regulatory Submissions & Compliance
Prepare, review, and submit regulatory dossiers under frameworks such as MDR, IVDR, FDA 510(k), PMA, and regional regulations (APAC, LATAM, EMEA).
Manage end-to-end submission lifecycle including gap analysis, remediation, tracking, and response management.
Ensure compliance with global regulatory requirements and submission standards.
Authority & Stakeholder Interaction
Coordinate directly with Notified Bodies and global health authorities.
Respond to regulatory queries and facilitate timely approvals.
Partner with internal stakeholders to ensure regulatory alignment across functions.
Cross-Functional Collaboration
Work closely with R&D, Quality, Manufacturing, and Product Development teams.
Ensure regulatory input is integrated into design and development documentation.
Support product lifecycle management and regulatory impact assessments.
Documentation & Systems Management
Maintain accurate regulatory documentation, databases, and submission records.
Oversee document control systems and digital submission platforms.
Ensure compliance with documentation standards and audit requirements.
Labeling & Post-Market Activities
Support labeling reviews and product change assessments.
Ensure post-market regulatory compliance and surveillance support.
Team Leadership & Mentoring
Manage and mentor regulatory specialists and junior team members.
Provide training, guidance, and performance review of deliverables.
Ensure consistency in execution across regional teams.
Process Improvement
Identify opportunities to improve regulatory submission workflows.
Enhance efficiency in documentation, tracking, and submission processes.
Required Qualifications
Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field.
Advanced degree preferred.
Minimum 12+ years of experience in global Regulatory Affairs for IVDs and Medical Devices.
Required Skills & Competencies
Regulatory Expertise
Strong knowledge of MDR, IVDR, FDA 510(k), PMA, and global regulatory frameworks.
Proven experience in global regulatory submissions and authority interactions.
Strong understanding of product registration processes across multiple regions.
Technical & Analytical Skills
Strong technical writing and documentation skills.
Ability to manage complex, multi-region regulatory submissions simultaneously.
Strong analytical and problem-solving capabilities.
Leadership & Collaboration
Proven leadership or team management experience.
Ability to mentor and guide regulatory professionals.
Strong cross-functional collaboration skills.
Experience working with global stakeholders and regulatory authorities.
Operational Skills
Ability to balance strategic planning with execution.
Strong organizational and project management skills.
Proficiency in regulatory submission tools and document management systems.
Working Environment
Office-based role with collaboration across global teams.
High-level exposure to regulatory authorities and international stakeholders.
Requires strong focus, accuracy, and ability to manage complex workflows.
Why Join This Role
Lead global regulatory strategy for high-impact medical technologies.
Work at the intersection of innovation, compliance, and market access.
Collaborate with global experts across R&D, quality, and manufacturing.
Play a key role in bringing medical devices and diagnostics to global markets.
Drive regulatory excellence in a leading global life sciences organization.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Kyiv |Lima Region :
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