Principal Regulatory Specialist - AI/ML

About Our Team
We're a dynamic and forward-thinking team at Shurig Solutions, Inc., united by our passion for innovation and excellence. Our employees embody a culture of collaboration, creativity, and continuous learning, which enables us to tackle complex challenges and achieve remarkable results. Join us as a Regulatory Affairs Specialist, and become part of a community that values diversity, inclusivity, and growth.

About the Role
In this vital position, you'll play a pivotal role in shaping our regulatory strategy, ensuring compliance, and facilitating timely submissions for our groundbreaking AI, ML, and cybersecurity initiatives. You'll work closely with cross-functional teams to develop comprehensive regulatory plans, coordinate US and EU filings, and foster key relationships with regulatory agencies. Your expertise will be instrumental in driving regulatory approvals for Class II and III electronic medical equipment devices.

Main Responsibilities
The successful candidate will be responsible for:
1. Contributing to the development of our regulatory strategy, aligning with business objectives and market trends
2. Collaborating with internal stakeholders to ensure seamless regulatory compliance across all product lines
3. Coordinating and submitting US and EU regulatory filings, including pre-submissions, 510(k)s, and CE Mark submissions under MDR
4. Providing expert guidance on relevant regulatory requirements, including Quality Systems standards and clinical investigations
5. Building and maintaining strong relationships with regulatory agency staff to facilitate open communication and cooperation
6. Participating in regulatory audits, ensuring compliance with established procedures and regulations
7. Assisting in the development and maintenance of our PCI guidance system and IVUS catheter technology
8. Staying up-to-date with evolving regulatory landscapes and making recommendations for adjustments to our strategy

Essential Requirements
Candidates should meet the following essential qualifications:
1. A minimum of a Bachelor's Degree from an accredited institution
2. At least 7 years of experience in regulatory affairs or a related field, or a Master's or PhD with 5 years of relevant experience
3. Proven expertise in regulatory affairs, with a focus on medical devices, quality systems, and clinical investigations
4. Excellent communication, interpersonal, and problem-solving skills, with the ability to work effectively in a fast-paced environment
5. Familiarity with software applications like Microsoft Office and Adobe Acrobat
6. Ability to work independently and lead cross-functional teams effectively

Desirable Qualifications
Candidates with the following desirable qualifications will be given preference:
1. Bachelor's Degree in life sciences, engineering, or a related field
2. Previous experience in the medical device industry with Class II device submissions
3. Direct experience working with FDA, notified bodies, and/or international health authorities
4. Prior experience with electrophysiology and/or medical electronic equipment products
5. Strong leadership, strategic thinking, project planning, and project management skills