Senior Manager, Regulatory Affairs
Quality Assurance – Los Angeles, CA – Full Time

About our Company

Founded in 2013 by three UCLA graduate students, NovaSignal Corp. is a medical technology company whose mission is to save lives by unlocking the hidden power of blood flow data. The company’s FDA-cleared Lucid™ Robotic System combines non-invasive ultrasound, robotics, and artificial intelligence to assess real-time cerebral blood flow. Through the use of cloud computing and data services, NovaSignal will support physicians in their clinical decision making, leading to better patient outcomes.

Summary of Position

The Senior Manager, Regulatory Affairs will serve a critical role throughout our products’ lifecycles. This individual will be responsible for developing regulatory strategies, preparing applications for FDA 510(k)s and CE marking, providing regulatory affairs support for new product development, and ensuring post market compliance of cutting-edge medical device products that incorporate artificial intelligence and cloud computing. The Senior Manager, Regulatory Affairs will also be responsible for interfacing with regulatory agencies around the world, potentially helping to shape how AI/ML and cloud-based devices are regulated.

Attributes of a Successful Candidate

• Hands on experience developing regulatory strategies and creating regulatory submissions for cloud and software based medical devices.
• Able to transition easily from high-level strategic influence to hands-on implementation and leadership

Essential Functions

• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes.
• Act as a liaison between the Company and applicable regulatory agencies (FDA, Health Canada, TGA, Notified Bodies, etc.)
• Responsible for obtaining the required regulatory approvals to market the Company’s products worldwide.
• Represent Regulatory Affairs on project team for both new and existing products.
• Review advertising, labeling and public communications for regulatory compliance issues.
• Assist in ensuring compliance to design control regulations during product development and delivery activities including the assessment of regulatory impact.
• Assist in developing regulatory strategy for new products and claims.
• Lead post market surveillance activities and reporting as needed
• Responsible for keeping management team informed of regulatory status of products and significant regulatory issues.
• Maintain working knowledge of applicable global regulations and provide counsel, training, and interpretation of regulatory requirements to company personnel.
• Support the quality management system to ensure regulatory compliance.
• Perform other responsibilities as required.

Requirements

• Bachelor’s degree in engineering or a related field
• 10-15 years of experience in medical device industry is required.
• Track record of successful regulatory submissions (510k, De Novo, PMA)
• Hands-on experience developing regulatory processes, procedures, and strategies in accordance with FDA, EU/ISO, Canadian, Asia-
• Pacific and Latin American regulations
• Direct experience with SaMD
• Experience with cloud-based products a plus
• Regulatory Affairs Certification preferred

Additional Perks/Benefits

NovaSignal takes pride in their employees and offers a variety benefits, wellness programs, and company perks including:

• Competitive Medical, Dental and Vision Plans
• Life Insurance
• Flexible Spending Accounts
• 401(K)
• Flexible PTO
• Paid Holiday and Sick Days
• Team Bonding Events
• Promoting from Within

EEO Statement

NovaSignal is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

DISCLAIMER

NovaSignal does not accept unsolicited resumes from search firm recruiters. Fees will not be paid in the event a candidate submitted by a recruiter without an agreement in place is hired; such resumes will be deemed the sole property of NovaSignal.

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