Director of Quality and Regulatory Affairs

Director Quality and Regulatory Affairs
This position is responsible for quality and regulatory aspects related to the design, development, manufacturing, registration and commercialization of products. This position works in a team environment, interacting with all departments throughout the company.
o Develop, implement, and maintain all aspects of an effective quality management system that meets the requirements of the Food and Drug Administration, ISO 13485:
2003, the EU Medical Device Directive, the EU In Vitro Diagnostic Device Directive, the Canadian Medical Device Regulations, and all other applicable standards.
oDirect internal audits to monitor the effectiveness of the quality management systems.
o Serve as Management Representative to oversee and report on the effectiveness of the quality management system to executive management, report on improvements needed, and ensure awareness of regulatory and customer requirements throughout the company.
oWorking closely with Engineering and Manufacturing, ensure that products are designed, developed, and manufactured in accordance with internal procedures and meet the requirements set forth in the application regulations and standards.
o Develop and monitor compliance with quality agreements with suppliers and contract manufacturers; conduct supplier selection and annual audits of suppliers and contract manufacturers as well as internal audits to monitor the effectiveness of the quality management system.
o Act as primary liaison with regulatory agencies and certifying bodies for all regulatory submissions, responses to inquiries, site inspections and all matters regarding compliance with quality system requirements and product complaints/problems.
o Plan and prepare all US and International regulatory submissions.
o Participate in the development and implementation of regulatory strategies based on US, EU and other International standards, regulations, legislations, and guidance.
o Coordinate the review of product labeling and advertising including, but not limited to, marketing promotional materials.
o Establish and implement company-wide documentation procedures used in fulfilling Quality System Regulation
(QSR) and Medical Device Directive (MDD) requirements.
o Responsible for all MDR and Vigilance reporting to regulatory authorities.
oDirect interactions with FDA, State Department of Health and the Notified Body during company inspections.
oProactively champion quality assurance issues where applicable in company-wide activities.
o Establish regular employee training in QSR and MDD regulations.
o Plan, schedule, and complete projects in a manner consistent with corporate objectives.
oRegularly make presentations to the Design Review group, Executive Staff, and Board of Directors as required regarding project status.
oProactively communicate project status to management.
o Develop and administer department budgets, schedules, and other administrative functions.
o Bachelor's degree, preferably in a scientific discipline or engineering
o Minimum of ten years of related experience in the medical device industry in addition to a minimum of three years of supervisory experience
o Demonstrated experience in QSR compliance, clearance of 510(k) and PMAs, and CE Marking of Class I and II medical devices
oAdvanced working knowledge of US and EU medical device regulations / legislation and applicable international standards including ISO 13485 to establish strategy, policies and procedures
o Experience interacting directly with US and International health authorities
o Knowledge of 21 CFR Part 11 compliance and software design verification/validation
o Proficient in MS Office programs (Word, Excel, PowerPoint), Visio, MS Project; experience with document templates and scientific reference software is desirable
oMust be detail-oriented with strong written and oral communication skills
o US and International travel may be required

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