Regulatory Project Manager – FSP

• Guide regulatory activities across medical devices, pharmaceuticals, biologics, and in-vitro diagnostics product lines
• Develop and implement regulatory strategies supporting product development, registration, and lifecycle management
• Provide strategic regulatory guidance
• Lead regulatory submission preparations
• Interact with regulatory authorities
• Manage regulatory intelligence activities
• Collaborate with Quality, R&D, Marketing, and other stakeholders throughout product development and commercialization
• Ensure regulatory requirements are met and drive regulatory excellence across the organization
• Manage and develop regulatory affairs staff
• Manage multiple regulatory projects simultaneously

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in pharmaceutical, medical device, or diagnostics industry
• Preferred fields of study: Life Sciences, Chemistry, Engineering, Pharmacy or related scientific field
• Regulatory affairs certifications beneficial
• Comprehensive knowledge of global regulations and guidelines (FDA, EMA, PMDA, NMPA)
• Demonstrated expertise in regulatory strategy development and implementation
• Strong experience with regulatory submissions (IND, BLA, NDA, 510(k), CE marking)
• Proven track record of successful interactions with regulatory authorities
• Experience managing and developing regulatory affairs staff
• Advanced understanding of GMP/QMS requirements and compliance
• Excellent project management and organizational skills
• Strong analytical and problem-solving capabilities
• Superior written and verbal communication skills
• Ability to influence and collaborate across all organizational levels
• Proficiency with regulatory information management systems
• Proven ability to manage multiple projects simultaneously
• Available for approximately 20% travel
• Business-level English proficiency required; additional languages beneficial

• Fully remote work arrangement
• Standard Monday-Friday work schedule