Senior Regulatory Affairs Manager (Medical Devices)
Overview
We are seeking a senior regulatory professional to lead device-focused regulatory strategy and submission activities within a global organization
This role supports the development, approval, and commercialization of medical devices across the U.S. and international markets
The position requires deep expertise in U.S. regulatory frameworks and global device regulations, along with the ability to guide cross-functional teams and drive successful regulatory outcomes
Key Responsibilities
1. Regulatory Strategy
Develop and execute regulatory strategies across product development, approval, and lifecycle management
Ensure alignment with global regulatory requirements including U.S. and international frameworks
2. Regulatory Submissions
Lead preparation and management of regulatory submissions such as pre-market applications and approvals
Oversee submission processes from early-stage planning through to final approval
3. Compliance & Documentation
Ensure adherence to applicable regulatory standards and quality systems
Maintain accurate, complete, and audit-ready regulatory documentation
4. Regulatory Intelligence
Monitor changes in global regulatory requirements and assess their impact on business and product strategies
Provide insights to support proactive regulatory planning
5. Cross-functional Support
Provide regulatory guidance to internal teams including R&D, clinical, quality, and commercial functions
Ensure alignment across stakeholders throughout the product lifecycle
6. Health Authority Interaction
Serve as a primary contact for regulatory authorities, managing communications, submissions, and responses
Support inspections and regulatory inquiries as needed
7. Leadership & Process Improvement
Contribute to the development of best practices and continuous improvement of regulatory processes
Collaborate with global teams to maintain high operational standards
Candidate Requirements
Education
Bachelor’s degree in Life Sciences, Engineering, or a related field
Advanced degree preferred
Core Skills & Expertise
Strong knowledge of medical device regulations and quality standards
Experience preparing regulatory documentation and managing submissions
Ability to assess regulatory risks and develop strategic plans
Strong project management and organizational skills
Effective communication and stakeholder management capabilities
Relevant regulatory certifications are a plus
Preferred Knowledge
Familiarity with global regulatory frameworks across multiple regions
Knowledge of emerging technologies such as digital health, software, or AI-based devices
Experience with investigational or clinical-stage device programs
Business-level English proficiency
Experience
10+ years of experience in regulatory affairs, including significant experience in medical devices
Proven track record of successful regulatory submissions and approvals
Experience working with higher-risk product categories preferred
Exposure to combination products or software-based medical technologies is a plus
Experience managing cross-functional projects in a global environment
Hiring Priorities
Candidates with strong regulatory leadership experience who can independently drive strategy and execution
Individuals with deep knowledge of global medical device regulations and a proven ability to navigate complex approval processes