Senior Director of Quality Assurance and Regulatory Affairs

Indianapolis, IN

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Summary:

The Sr. Director of Quality Assurance and Regulatory Affairs is responsible for designing, planning, implementing, directing and evaluating the Quality Management System to ensure compliance is maintained with all regulations and standards, regulated activities, USA 510(K) submissions and international product approvals and registrations.

Duties and Responsibilities:

Manage the QARA team to ensure it is meeting established performance expectations and provide development opportunities.

Develop and manage a Quality Management System to delineate areas of responsibility, personnel requirements, and operational procedures according to and consistent with company goals and policies.

Serve as Management Representative during audits (FDA, ISO and various on-site and off site inspections, assessments and audits) to ensure Quality System requirements are effectively established and maintained and report on the performance of the Quality System to management with executive responsibility.

Coordinate all quality procedures (QA manual, standard procedures, work instructions).

Ensure product quality meets or exceeds performance targets.

Ensure quality audits are conducted and are effective to ensure the Quality System is functioning as planned.

Develop, revise, review and approve policies and procedures, as required.

Ultimately responsible for managing processes related to the handling of complaints, non-conformances, internal audits, and the CAPA system.

Create materials for and conduct quality training with the training head.

Review and edit material related to regulatory submissions, such as FDA Pre-Market Approval, as needed.

Responsible for regulatory submissions including IDEs, PMAs, 510(k)s, and their associated supplements and annual reports.

Support new country registrations and manage re-registrations for commercial use.

Ultimately responsible for QA and RA reviews of project deliverables, engineering change notices, engineering change requests.

Ultimately responsible for RA review and approval of all marketing materials.

Manage translation process for user manuals and software.

Other team projects as assigned.

Qualifications/Specifications:

Bachelor’s degree required, preferably in Engineering

Minimum of 10 years of quality system design and implementation experience in the medical device industry ISO 13485 and FDA QSR expert

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

Minimum of 10 years of experience with FDA De Novo, 510(K), Medical Device Directive and other international country device registrations

Strong leadership and interpersonal communication skills.

Self-motivated with a proactive attitude and the ability to work independently.

Familiar with departmental policies, SOPs, goals, and objectives.

Strong problem-solving and decision-making skills.

Strong written and oral communication skills.

Strong analytical and troubleshooting skills.

Strong organizational and project management skills.

Team based department – open, honest communication is a must

Computer proficiency (Microsoft Office Suite, SharePoint).

 

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