Senior Regulatory Affairs Specialist

📋 Description

• Interpret and apply U.S. and international regulatory requirements for medical devices and IVD
• Develop regulatory strategies and provide assessments of regulatory risks, options, and appropriate
• Prepare and manage U.S. regulatory submissions, including 510(k)s, PMA applications and
• Coordinate information and documentation required for international product registrations and
• Interact and negotiate with U.S. regulatory agencies and coordinate responses to additional data or
• Review clinical protocols and monitor clinical studies to ensure appropriate data is collected to

🎯 Requirements

• Bachelor’s degree or equivalent; a degree in biological sciences, chemistry, or a related
• At least 5 years of experience in the medical device, diagnostic, biologic, and/or pharmaceutical
• Current knowledge of U.S. medical device and IVD regulatory requirements, including Good Laboratory
• Familiarity with European medical device and IVD regulatory requirements and applicable European
• Strong written and verbal communication skills, with the ability to effectively collaborate with
• Strong organizational skills and the ability to manage multiple priorities in a regulated

🎁 Benefits

• Remote position available across the United States.
• Annual base salary range of $83,000–$103,700 USD, with actual compensation determined by factors
• Comprehensive medical, dental, vision, life, and disability benefits for eligible employees and
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby-bonding leave.