Job details

Senior Specialist, Regulatory Affairs

Get a free resume review

Develop regulatory submissions for domestic and international spinal product clearances. Duties include:

Develop and implement robust global regulatory strategies for medical devices, software as a medical device (SaMD), and AI/machine learning (ML)-based medical devices and technologies to ensure compliance with global regulatory requirements, including with the US FDA and other regulatory bodies;
Establish and monitor compliant software lifecycle processes in alignment with IEC 62304 standard for medical device software. Collaborate closely with cross-functional software development teams to embed regulatory compliance at every stage, including design, development, verification and validation, risk management, and post-market surveillance, to meet stringent regulatory standards for safety and performance;
Implement IEC 62366-compliant usability engineering processes, ensuring that all devices, including SaMD and AI-based systems, meet stringent human factors requirements. Carry out usability testing, develop risk mitigation strategies to reduce user-related errors, and review comprehensive human factors engineering reports to ensure compliance and to mitigate regulatory risk;
Provide technical regulatory expertise for medical devices integrating hardware and software components, ensuring compliance with IEC 60601 standards for electrical safety, electromagnetic compatibility, and essential performance. Act as a regulatory authority within project teams, ensuring risk management and electrical safety standards are strictly met;
Integrate cybersecurity requirements into the organization’s Quality Management System (QMS), ensuring adherence to the latest FDA guidance and cybersecurity standards (i.e., IEC 81001-5-1, and SW96:2023). Develop comprehensive regulatory strategies and work closely with cross-functional teams (i.e., software engineering, IT, and quality) to establish policies for secure coding practices, vulnerability management, and post-market cybersecurity vigilance;
Stay abreast of emerging regulatory frameworks and guidance for AI and machine learning-based medical devices. Conduct gap analyses to assess organizational readiness for implementing FDA’s Total Product Lifecycle (TPLC) approach to AI/ML-based devices. Carry out initiatives to ensure safety, effectiveness, transparency, and real-world performance monitoring through real-time data analytics and continuous risk management in accordance with FDA guidelines and global best practices;
Prepare, review, and submit regulatory documentation, including FDA pre-submissions, 510(k) submissions, and international equivalents (e.g., CE Marking, TGA, Health Canada, and PMDA), ensuring full compliance with country-specific requirements and guidelines for product registration and market entry. Ensure all protocols, reports, engineering documentation, and product manufacturing records align with regulatory requirements, such as ISO 13485 and ISO 14971.

Minimum Requirements:

A Master’s degree or foreign equivalent in Regulatory Affairs, Pharmacy, Biomedical Engineering, or a related field followed by 3 years of post-baccalaureate experience in a regulatory affairs specialist-related occupation.

Experience must include the following, which may have been gained concurrently:

1) 3 years of experience with U.S. FDA regulations, European Union Medical Device Regulations (EUMDR), Health Canada, PMDA, and TGA regulations;

2) 2 years of experience in the medical device industry;

3) 2 years of experience with 21 CFR 820 (Design Controls) and ISO 13485 for Quality Management Systems to ensure regulatory compliance across product lifecycle stages;

4) 2 years of experience applying ISO 14971 for risk management in medical device development, including the identification, assessment, and mitigation of risks to ensure device safety and effectiveness;

5) 2 years of experience guiding usability engineering processes in compliance with IEC 62366, including human factors engineering (HFE) assessments and usability testing for medical devices;

6) 2 years of experience with regulatory compliance for electrical safety, electromagnetic compatibility, and essential performance standards (IEC 60601 standards) for medical devices;

7) 1 year of experience implementing and monitoring software development lifecycle processes in compliance with IEC 62304 for medical device software;

8) 1 year of experience developing and implementing cybersecurity strategies for medical devices in line with FDA guidelines and cybersecurity standards.

Job site: 1950 Camino Vida Roble, Carlsbad, CA 92008. Full-time. Salary: $128,700 - $145,000.

To learn more & to apply online, visit our website at: https://atecspine.com/careers/ & reference Req: Senior Specialist, Regulatory Affairs.

522349051v.1

Average salary estimate

$136850 / YEARLY (est.)

min

max

$128700K

$145000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Senior Specialist, Regulatory Affairs, Alphatec Spine

Are you a detail-oriented professional excited about shaping the future of medical technology? ATEC Spine is looking for a Senior Specialist in Regulatory Affairs to join our dynamic team! In this role, you will lead the development of regulatory submissions for both domestic and international spinal product clearances, paving the way for our innovative medical devices, including software as a medical device (SaMD) and AI/ML-based technologies. Your responsibilities will encompass creating robust regulatory strategies compliant with global standards, collaborating with development teams, and ensuring safety and efficacy through stringent verification processes. You will also apply your expertise to establish compliant software lifecycle processes and implement usability engineering practices that meet IEC standards. You’ll play a crucial role in mitigating regulatory risks related to human factors and cybersecurity while staying ahead of rapidly evolving regulations for medical devices. With a focus on compliance with U.S. FDA and international guidelines, you will prepare key regulatory documentation such as FDA pre-submissions and 510(k) submissions. If you possess a Master’s degree in Regulatory Affairs or a related field and have three years of experience in regulatory affairs, particularly in the medical device sector, ATEC Spine could be the perfect place for you to grow and make an impact. We offer a full-time position with a competitive salary range of $128,700 to $145,000. Join us in advancing the standards of spinal care through innovative solutions and expert regulatory guidance!

Frequently Asked Questions (FAQs) for Senior Specialist, Regulatory Affairs Role at Alphatec Spine

What are the key responsibilities of a Senior Specialist, Regulatory Affairs at ATEC Spine?

As a Senior Specialist in Regulatory Affairs at ATEC Spine, you will be responsible for developing regulatory submissions for spinal products, establishing global regulatory strategies, monitoring software lifecycle processes, and ensuring compliance with standards like IEC 62304 and IEC 60601. Additionally, you’ll implement usability engineering practices and cybersecurity strategies to mitigate regulatory risks across product development.