Quality and Regulatory Project Manager
The Quality and Regulatory Project Manager provides project leadership in support of the Global Quality System with respect to managing projects such as implementing process changes, quality / regulatory projects and software implementations that drive continuous improvement and compliance through the utilization of industry best practices. The position ensures compliance to governmental regulations such as US FDA requirements, ISO 13485, EU MDR, and other international standards and requirements as appropriate. This position leads or supports business critical changes where the scope and complexity of responsibilities require the integration of multiple disciplines and departments (e.g., Quality, Regulatory, Engineering, Manufacturing, Operations, IT) under the general direction of management.
- Leads global quality system, regulatory and/or software development projects at a site, multisite, or global level as defined by management to drive continuous improvement while ensuring compliance to applicable regulations and standards. Develops and manages project plans with defined milestones, budgets, and deliverables; coordinates and holds project team members accountable to assigned activities.
- Identifies processes to be improved and develops and implements new processes and procedures to address gaps.
- Leads/Supports the design, validation, implementation and maintenance of the quality data systems and the IT strategy associated with such systems. Implements risk-based approach to ensuring systems compliance with regulations and industry guidelines.
- Establishes and builds relationships with internal partners to support management objectives.
- Performs other duties/responsibilities as assigned by management.
Overall Experience Requirements:
- The position requires 6-9 years of direct medical device industry experience with a Bachelor’s Degree or 4-7 years of direct medical device industry experience with a Master’s Degree.
Other Required Skills:
- Demonstrated knowledge and experience in the medical device industry
- Ability to travel domestically and internationally
- Demonstrated successful interactions with cross-functional project teams
- Software and process validation and verification experience
- Solutions-oriented and skills/knowledge to manage complex problems and projects
- Relational database and software infrastructure knowledge
- Experience with standard business applications such as Microsoft Office
- Strong communication and presentation skills
- Strong analytical skills
- Ability to work with minimal guidance and manage project deliverables and timelines
- Proven project management principles
- Previous background and experience with other related functions, including product development, engineering and manufacturing / operations
- Advanced degree in a technical or business field preferred
- Industry certifications in Process Excellence (e.g., Six Sigma Green Belt/Black Belt), ASQ (e.g., CQM, CQE, CQA), and project management (e.g., PMP)
- ISO 13485 Lead Auditor training
- Experience with industry-specific business/software applications such as Minitab and quality systems applications