Quality & Regulatory Director at Integrated Talent Strategies

Department: Quality and Regulatory Affairs
Reports To: President & CEO

Summary of Position

The Quality Assurance / Regulatory Affairs Director is responsible for the regulatory & quality assurance of all products, quality system management, and manufacturing process quality and customer problem resolution across both the US and in international markets. This position is responsible for maintaining ISO certification, FDA compliance, International regulatory compliance, OSHA compliance, supporting continuous improvement activities and all results related to product quality, performance, and safety.

Essential Duties and Responsibilities

Works closely with Operations and R&D to develop and implement appropriate risk management, qualification, verification, and validation plans Assesses, provides recommendations, and leads implementation of systems, processes and equipment for improvement and compliance to ISO 13485 within the Manufacturing & Operations, R&D, Quality and Regulatory processes. Supports company goals and objectives, policies and procedures in compliance with quality systems and FDA regulations and International regulations. Supports the CAPA process, collaborating with other departments to ensure effective root cause analysis and the development of innovative, long-term solutions. Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices. Tracks effectiveness of corrective action plans and compliance improvement initiatives. Responsible for supporting the quality control functions which may include assisting with sampling plans, supplier development, and quality training. Prepares and reviews qualification and validation test plans and reports for new projects. PRRC- Among additional duties, the main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745: Conformity of the product device to the Medical Device Regulation and Quality Management System Conformity of the Technical Documentation and EU Declaration of conformity Compliance with Post-Market Surveillance (PMS) following Article 10(10) Compliance with the Vigilance Reporting obligations (Article 87 to 91)

Supervisory Responsibilities

Responsible for directing the activities for Quality Assurance Specialist, Quality Engineer and Regulatory Affairs Specialist. Responsible for managing outside consultants required to maintain ISO 13485 and global regulatory clearance.

Authorities for Position

Heads Quality and Regulatory Affairs for all division product lines for sales in the US and Internationally. Official Correspondent for FDA (OC) Management Representative (MR) Person Responsible for Regulatory Compliance (PRRC) Takes the lead on audits when dealing with the FDA, Health Canada, EU and other regulatory bodies. Responsible for planning, organizing, directing, and reporting on all Supplier Quality activities and performing Supplier Quality Audits. Manage relationships with European Authorized Representative and Notified Bodies

Competency Required for Position

Full knowledge of ISO 13485 QM System requirements as applied to Bionix Development Corporation Full knowledge of FDA 21CFR 820 requirements for medical device company EU MDR (2017/745). Expertise in regulatory requirements for targeted foreign markets, including Europe, Canada, Australia, Middle East and Central/South America Ability to lead implementation and consistent use of QMS throughout company

Qualifications Required for Position

Minimum of a four-year college degree preferred Five or more years of quality management experience Five or more years of U.S. regulatory experience Five or more years of International regulatory experience

Work Environment

General office environment Warehouse and light manufacturing environment Some travel is required to visit vendors