Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

• Job Description Job Title: Regulatory Affairs Manager
• Market Access
  Joining Thermo Fisher Scientific means engaging in meaningful work that positively affects the world. Our colleagues bring our Mission to life daily, helping customers create a healthier, cleaner, and safer planet. We equip our global teams with resources to reach personal career objectives while advancing science through solutions addressing challenges like environmental protection, food safety, and cancer research.

Position Summary: The purpose of this role is to increase market access for Microbiology Division’s (MBD) clinical IVD products through successful pre-market licenses, renewals, and strategic market analysis. This position focuses on navigating regulatory requirements to enable global market entry through licensing and regulatory strategy. This role is responsible for leading a team of nine regulatory professionals who craft submissions based on product technical data and capture vital regulatory intelligence. The key interfaces for this position include the Global Regulatory Affairs team, Marketing, Sales, and Thermo Fisher regional RA shared services.

The Regulatory Affairs Manager:

• Market Access reports to the Director of Global Regulatory Affairs and is a member of the global RA leadership team for Microbiology.

Responsibilities:

• Regulatory Licensing and Compliance: Acquire pre-market licenses, handle renewals, and maintain license changes globally. Ensure regulatory pathways, documentation, and country-specific requirements are accurately interpreted and implemented.
• Market Access Strategy and Analysis: Perform market assessments to aid regulatory pathways and worldwide market introduction.
• Regulatory Intelligence: Acquire, assess, and communicate actionable regulatory intelligence across global teams.
• Operational Excellence: Develop and monitor key performance indicators related to licensing activities. Drive continuous improvement initiatives to reduce time-to-license, improve submission quality, and optimize global processes.
• External Engagement: Engage with healthcare providers and regulatory authorities to support submission discussions, clarify regulatory expectations and answer questions.
• Cross-Functional Coordination: Collaborate with Regulatory Affairs, Marketing, Sales, Product Management and Quality on market access strategies, product compliance and lifecycle changes.
• Leadership & Team Development: Direct and mentor a team of regulatory professionals by communicating clear objectives, prioritizing tasks, and upholding accountability. Support personal development, professional progression, and a positive workplace culture.

Minimum Qualifications:

• Bachelor’s/Master’s Degree or equivalent experience, diploma, or equivalent combination of qualifications in life science, engineering, legal, or related fields.
• Validated experience with international regulatory affairs within the medical device or IVD industry.
• Over 5 years of experience in regulatory affairs, including handling global submissions and market entry.

Skills:

• Excellent regulatory communication and presentation skills at all organizational levels.
• Expertise in multinational regulatory strategy, risk-benefit analysis, and collaboration with internal and external partners.
• Strong project management skills with the ability to manage complex global portfolios and prioritize competing deadlines.
• Ability to develop and engage in a high-performance team dedicated to accountability.
• Capability to lead, influence, and innovate within a cross-functional environment.