Compliance and Regulatory Expert

About Our Culture
We value diversity, inclusivity, and growth at Shurig Solutions, Inc. Our culture is built on a foundation of collaboration, creativity, and continuous learning. We believe in empowering our employees to take ownership of their work, providing opportunities for growth and development, and fostering an environment that promotes well-being and job satisfaction. Join our dynamic team as a Regulatory Affairs Specialist, and become part of a community that shares your passion for innovation and excellence.

About the Position
This prestigious Regulatory Affairs Specialist position offers an unparalleled opportunity to drive regulatory strategy, compliance, and submission strategies for our cutting-edge AI, ML, and cybersecurity initiatives. You'll work closely with cross-functional teams to develop comprehensive regulatory plans, coordinate US and EU filings, and build key relationships with regulatory agencies. Your expertise will be instrumental in securing timely approvals for Class II and III electronic medical equipment devices.

Main Responsibilities
The selected individual will be responsible for:
1. Developing and implementing regulatory strategies that align 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 Qualifications
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