Our small start-up client is adding a Regulatory Assurance Manager to the team. The RA Manager will work cross-functionally and be responsible for providing regulatory assurance representation on engineering, operations, and clinical teams. The manager will also provide input for process/product improvements.

Your role with the company:

·       This position takes ownership of the Quality Management System (QMS) and is responsible for QMS process development and execution.

·       This position has shared responsibility for product safety and quality in all stages of product and process development, and ensuring regulatory compliance with design specifications, quality management system procedures, and all applicable regulatory requirements.

·       Responsible for standardizing documented quality tools such as root cause analysis, flowcharts, cause and effect diagrams, control charts, and statistical methods.

·       Responsible for the development, improvement, and management of regulatory assurance processes such as document control, training, QMS processes, audits, CAPA, post-market surveillance, and change management.

·       Responsible for tracking, analyzing, and reporting on quality and business measurements such as complaints, NCMRs, and CAPAs

  Manage RA staff and technical improvement projects

·       Technically excellent with deep and broad experience in RA

·       Hands on, dives in, takes ownership

·       Data visibility and integration into our RA, DA, and QA processes

·       Use of Quality Tools - routine use of documented root cause analysis and other Quality Tools

Manage Products

·       Responsible for Regulatory Assurance activities for capital, reusable, disposable, and software products, including regulatory submissions, product release authorization, change management, post-market surveillance, quality management system, internal and external audits, documentation control, and training

·       Deep knowledge of medical device development regulations and standards, and ability to apply and teach this knowledge broadly across the organization as we strive toward quality excellence

Manage Processes

·       Data Analysis: standardized use of statistical tools across QMS, data visibility and integration into our processes, broad implementation of JMP

·       Root Cause Analysis: standardized documented use of Quality Tools

·       Develop efficient and effective RA processes

·       Change management regulatory review and approval

·       Product release authorization

·       Post-market surveillance

·       Quality management system SOPs and management reviews

·       Audit management: internal and external

·       Documentation controls

·       Training management

·       Corrective and Preventive Action (CAPA) – QMS related CAPAs, ownership and development of CAPA processes including periodic CAPA reviews

·       Process excellence: work cross-functionally to improve (simple, clear, efficient) all QMS processes and make data visible to all employees and management for making excellent risk-based decisions

Desired profile:

 BS engineering (EE, ME, BME) or four year degree 

Certifications (ASQ, CQE, SSBB, MQ/OE, CSCP, CQA, PMP) 

Experience managing people and in-depth knowledge of Quality Management System processes

• Minimum 10 years of experience working in the medical device industry.

·       Breadth across development timelines, across functions, and company sizes

·       Depth into each area of RA and QA, hands-on involvement, experience, and learning

• Proficient in statistics and statistical software, preferably JMP

·       Curiosity, learning, strong work ethic, getting involved, continuously improving

·       Outstanding integrity, character, and trustworthiness; demonstrated evidence of leadership, creativity, adaptability, determination, perseverance, and excellent communication

·       Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community in all areas of Quality Assurance

• Expert in statistics, statistical software, and Quality Tools a plus