Director of Regulatory Affairs for Medical Devices - Shaping Regulatory Strategies and Ensuring Compliance

Join a Leading Spinal Medical Device Company as a Director of Regulatory Affairs Are you a seasoned regulatory affairs professional looking for a challenging and rewarding role in the medical device industry? Do you have a passion for shaping regulatory strategies and ensuring compliance with FDA regulations and international standards? If so, we have an exciting opportunity for you to join our team as a Director of Regulatory Affairs, based in San Diego, California, with the flexibility of remote work. Our company is a leading player in the spinal medical device industry, dedicated to developing innovative solutions that improve patient outcomes. We're committed to fostering a culture of excellence, collaboration, and continuous learning, and we're looking for a talented Director of Regulatory Affairs to drive our regulatory efforts forward. About San Diego: A Lifestyle Upgrade San Diego is more than just a city - it's a lifestyle upgrade. With its year-round sunshine, pristine beaches, and vibrant cultural scene, San Diego offers the perfect blend of personal and professional growth. Imagine waking up every morning to a new adventure, whether it's hiking, surfing, or exploring the city's many attractions. As a resident of San Diego, you'll enjoy a high quality of life, with endless opportunities to pursue your passions and interests. Key Responsibilities: Shaping Regulatory Strategies and Ensuring Compliance As our Director of Regulatory Affairs, you will play a critical role in shaping our regulatory strategies and ensuring compliance with FDA regulations and international standards. Your key responsibilities will include: Lead Regulatory Strategy: Develop and implement comprehensive regulatory strategies for our US Class II implants and instruments, ensuring alignment with business objectives and regulatory requirements. FDA Expertise: Lead 510(k) premarket notifications for US FDA clearance, ensuring timely and successful submissions. Global Impact: Prepare regulatory submissions for Australia, including STEDs, EPCs, and DoCs, and ensure compliance with international regulatory requirements. Process Excellence: Improve regulatory processes, evaluate data and metrics, maintain databases, and ensure information accessibility and transparency. Collaboration and Leadership: Collaborate with cross-functional teams, including R&D, Quality, and Marketing, to ensure regulatory input and guidance throughout the product lifecycle. Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and industry trends, providing insights and recommendations to inform business decisions. Requirements: The Ideal Candidate To thrive in this role, you should have a strong background in regulatory affairs, with a minimum of five years of experience in the medical device industry. Your qualifications should include: Education: A Bachelor's degree in engineering, life sciences, or a related field. Regulatory Knowledge: Strong understanding of FDA Quality System Requirements (QSR) and ISO 13485, with experience in 510(k) submissions and other regulatory frameworks. Submission Expertise: Proven track record of successful regulatory submissions, including 510(k) clearances and international regulatory approvals. Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills, with the ability to interpret complex regulatory data and develop effective solutions. Communication and Collaboration: Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and stakeholders. Preferred Qualifications While not required, the following qualifications are highly desirable: Advanced Degree: A Master's degree or Ph. D. in a related field, such as regulatory affairs, engineering, or life sciences. Regulatory Certification: Certification in regulatory affairs, such as RAC (US) or RACP (Canada). International Regulatory Experience: Experience working with international regulatory frameworks, such as EU MDR, CFDA, or Health Canada. Leadership Experience: Proven leadership experience, with a track record of managing teams and driving regulatory efforts forward. What We Offer: Career Growth, Learning Benefits, and a Collaborative Culture As a Director of Regulatory Affairs at our company, you'll enjoy a range of benefits and opportunities, including: Career Growth: Opportunities for professional growth and development, with a clear path for advancement. Learning Benefits: Ongoing training and education, with access to industry conferences, workshops, and online resources. Collaborative Culture: A collaborative and dynamic work environment, with a team of experienced professionals who share your passion for regulatory affairs. Competitive Compensation: A competitive salary and benefits package, with opportunities for bonus and stock options. Work-Life Balance: A flexible work arrangement, with the ability to work remotely and maintain a healthy work-life balance. Why Join Our Team? If you're a motivated and experienced regulatory affairs professional looking for a challenging and rewarding role, we encourage you to apply now. Our company is committed to fostering a culture of excellence, collaboration, and continuous learning, and we're looking for talented individuals to drive our regulatory efforts forward. As a Director of Regulatory Affairs, you'll play a critical role in shaping our regulatory strategies and ensuring compliance with FDA regulations and international standards. Join our team and take the next step in your career. Apply now and discover a world of opportunities in beautiful San Diego! Ready to Apply? If you're ready to join a leading spinal medical device company and take on a challenging and rewarding role, we encourage you to apply now. Please submit your resume and cover letter, and we'll be in touch to discuss your qualifications further. Apply for this job