Lead IT quality efforts for software, mobile applications, and wearable technologies as medical devices. Keep abreast of and others apprised of regulatory, quality, compliance, and security issues affecting software, mobile applications, and wearable technology medical devices. Identify best practices in software, mobile applications, and wearable technology medical device quality and propagate these practices throughout the global IT community. This position will lead BTS quality organizations across AbbVie both directly and indirectly.
- Responsible for compliance with applicable regulations, standards, and Corporate Policies.
- Primary liaison between IT, Operations, and R&D organizations for Digital Health Quality.
- Develop and implement a process for assessing software, mobile applications, and wearable technologies as regulated medical devices.
- Lead the strategy, execution and implementation of Quality Management System (QMS) processes for developing software and mobile applications as regulated medical devices.
- Own and maintain AbbVie’s process for developing software and mobile applications as regulated medical devices.
- Develop AbbVie’s roadmap for FDA Digital Health Software Precertification.
- Lead Supplier Evaluation process for vendors relevant to Digital Health projects.
- Oversee staff responsible for the analysis of business processes and management of design history file system documentation including design and development plans, system requirements, functional specifications, etc.
- Ensure compliance to Quality System Regulations, ISO 13485, IEC 62304, 21 CFR Parts 11 and 820, FDA General Principals of Software Validation, Regulatory requirements, EU MDR etc.
- Bachelor's Degree in Science, Engineering or applicable discipline.
- Minimum of 10 years’ experience with, or exposure to, business functions such as IT, Compliance, Quality, Operations, Supplier Management and R&D.
- Minimum of 5 years’ experience in Medical Device industry
- Overall management experience - 5 years.
- Ability to drive, influence, and manage change. Strong organizational, analytical, and problem-solving skills.
- Excellent communication skills including a high energy level and ability to deal constructively with conflict.
- Ability to build strong relationships with peers and cross functionally and ability to influence and persuade key stakeholders.
This position reports to the Director of BTS Quality and is actively engaged with BTS, Quality and R&D leadership teams.
This position is part of AbbVie’s Information Security & Risk Management (ISRM) team. We are here to put our partners in a position to succeed. We do it by providing the knowledge, tools, and support they need to effectively use data and technology while also effectively managing risk.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced