EMEA Regulatory Strategy Lead for Medical Devices & Pharma

ThermoFisher Scientific; Netherlands; Remote; EUR 120,000 - 160,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Manager of Regulatory Affairs to lead global regulatory compliance activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics. You will guide regulatory strategies for development, registration, and lifecycle management, and interact with authorities to ensure timely approvals.

You will collaborate with Quality, R&D, Marketing, and other stakeholders to ensure regulatory requirements are

Qualifications

• Advanced degree with 6+ years in regulatory affairs (pharma/medical device/diagnostics).
• Experience leading regulatory strategy and submissions.
• Proven collaboration with authorities and cross-functional teams.

Responsibilities

• Provide strategic regulatory guidance across product lines.
• Lead submission preparations and interactions with regulatory authorities.
• Manage regulatory intelligence and ensure lifecycle compliance.
• Collaborate with Quality, R&D, Marketing, and other stakeholders.

Skills

Regulatory affairs experience

Regulatory strategy development

Regulatory submissions

Leadership / staff development

Education

Advanced degree

Bachelor's degree

Job description

Thermo Fisher Scientific is seeking a Senior Manager of Regulatory Affairs to lead global regulatory compliance activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics. You will guide regulatory strategies for development, registration, and lifecycle management, and interact with authorities to ensure timely approvals.

You will collaborate with Quality, R&D, Marketing, and other stakeholders to ensure regulatory requirements are