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  • gwenross1

VP, QUALITY ASSURANCES AND REGULATORY AFFAIRS

Indianapolis, IN


Are you self-motivated? Excited by working in smaller teams where opportunity to rise to frequent and diverse challenges is presented?

Come help us change the standard of care!

Sonablate develops non- and minimally invasive medical devices aimed at changing the way urological diseases are treated. More than 25,000 men have benefited from our products, using our patented high intensity focused ultrasound (HIFU) technology.


The Role

As the Vice President of Quality Assurance and Regulatory Affairs (VP, QA/RA), you will be a part of Sonablate's executive team with the primary responsibility of building and maintaining Sonablate's Quality Systems. This role is strategically important for the success of Sonablate’s commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets.


You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company.


This role, ideally suited to a candidate who is self-motivated and excited by a start-up environment where opportunity to rise to frequent and diverse challenges is presented.


Responsibilities

Responsible for development, implementation, maintenance, and overall success of the company’s quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality


Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for Sonablate’s products and ensure alignment with Sonablate’s overall business strategy


Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets


Ensure that regulated processes and systems in Sonablate are always inspection-ready


Oversee the performance of internal and external audits


Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs


Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions


Serve as PRRC


Other team projects, as assigned


Qualifications

Bachelor’s degree required in a science or engineering field


Minimum of 10 years of experience in QA/RA leadership roles


Experience in Class I and II medical devices/systems


Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT)


Extensive experience hosting regulatory inspections and interacting with regulators


Strong understanding of global registration requirements and demonstrated track record of successful market access. Experience with NMPA in China, a plus


Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution


Solid understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices


Effective leader with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management


Proven ability to create culture of accountability and ownership


The Company

Welcome to an established company, with a proven product, and a start-up feel. Sonablate Corp. was created following an acquisition of SonaCare Medical, LLC in 2021. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China.


Sonablate Corp. has two offices: one in Charlotte, NC and the other in Indianapolis, IN as well as remote employees spread out across the country.


Sonablate provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.


If you’re interested in joining our team, please apply!





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