Senior Regulatory Affairs Specialist - Manager

Senior Regulatory Affairs Specialist - Manager

Carlsbad - US

What we value:

• Honesty & Integrity: Uphold ethical standards and a strong work ethic.
• Passion & Curiosity: Show enthusiasm for medical device engineering and continuous learning.
• Problem Solving & Learning Ability: Demonstrate problem-solving skills and seek professional growth.

Key responsibilities:

• Lead the regulatory strategy for new product development and market entry, including 510(k), PMA, and CE Mark submissions.
• Prepare, review, and manage regulatory submissions to global authorities such as FDA and EMA.
• Collaborate cross-functionally with R&D, Quality, Clinical, and Marketing to align product development with regulatory requirements.
• Maintain regulatory compliance throughout the product lifecycle and monitor updates to global regulations.
• Manage timelines and deliverables for multiple regulatory projects, ensuring successful product launches.
• Mentor junior regulatory team members and foster a culture of compliance and continuous improvement.

What we are looking for:

• Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree a plus).
• 5+ years of medical device regulatory experience with a strong track record of successful submissions.
• Expertise in FDA, ISO, and EU MDR regulatory frameworks.
• Hands-on experience with 510(k), PMA, and CE Marking submissions.
• Excellent project management, communication, and leadership skills.
• Experience mentoring junior staff and working in cross-functional teams.

What we offer:

• Impactful work in the medical device industry.
• Collaborative environment and career development.
• Comprehensive benefits, including medical, dental, vision, 401(k), and PTO.