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.
