Senior Manager, Regulatory Affairs

Merit Medical

Medical Devices

Madrid - Spanien

Director

Experteer Overview

In this role you lead regional Regulatory Affairs for EMEA and CIS, shaping strategies to secure timely, compliant market approvals and align with business goals. You partner with commercial, operations, and platform teams to harmonize regulatory approaches and support market access. You will oversee regulatory activities, recalls reporting, and submissions, while maintaining deep regional knowledge. Your leadership drives a high-performing RA function and proactive regulatory advocacy across the region. This is an opportunity to influence regulatory strategy at scale and shape patient outcomes through cross-functional collaboration.

Compensation / Benefits

flexible working hours
competitive salaries
learning opportunities and internships

Responsibilities

Define and drive regulatory strategies for EMEA/CIS to align with business goals
Oversee regulatory activities and compliance across EEMEA/CIS/EU (non-CE mark)
Manage recall reporting and field actions within the region
Develop and maintain strong cross-functional partnerships with commercial, operations, and quality
Lead regulatory submissions with partners to ensure accuracy and timeliness
Communicate effectively with regulators to safeguard Merit’s reputation
Maintain and optimize the regional license portfolio in line with commercial strategies
Demonstrate leadership through talent development, coaching, and performance management
Create and improve regulatory processes, budgets, and resource allocation
Ensure compliance with promotion/advertising rules and monitor regulatory trends

Key requirements

8+ years of progressive Regulatory Affairs leadership in the medical device industry
Bachelor in Life Sciences (Master’s preferred) and relevant regulatory certifications (e.g., RAC) preferred
Proven leadership in managing regulatory teams within a global organization
Deep knowledge of regulations in primary EEMEA/CIS markets
Strong business acumen and clear stakeholder communication

strategic collaboration clear communication leadership and mentoring regulatory strategy and submissions compliance and quality systems regulatory data management

Description

In this role you lead regional Regulatory Affairs for EMEA and CIS, shaping strategies to secure timely, compliant market approvals and alig…

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