Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist will be responsible for planning, authoring, managing, and implementing regulatory submissions to the US FDA, EU Notified Bodies, and global regulatory agencies. This role supports worldwide product approvals and registrations, while ensuring continued compliance with regulatory requirements.

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• Minimum of 7 years' experience in regulatory affairs or related field, or 5 years' experience with an advanced degree (Master’s or PhD).
• Proven knowledge of U.S. and EU regulatory requirements for medical devices, including clinical investigations and Quality Systems standards.
• Experience authoring a variety of regulatory submissions (510(k), PMA, CE Mark under MDR, etc.).
• Solid understanding of product development, clinical development, manufacturing, and change control.
• Strong problem-solving and research skills, along with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Benefits

• Competitive salary
• Comprehensive benefits package
• Opportunities for career advancement
• Diverse and inclusive workplace
• Recognition for innovation and dedication