Medtronic
Senior Product Development Compliance Specialist (Finance)
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe
The Senior Compliance Specialist position has the primary responsibility to oversee and manage the PDP (product development process) and compliance-related initiatives within the Coronary (CRDN), Structural Heart and Aortic (SH&A), Cardiac Surgery (CS), and Peripheral Vascular Health (PVH).
Reporting to the Sr. Director of PMO, this position will be part of the DECO group (Design Control Compliance Office) within the PMO (Project Management Office). This position will work with cross functional project teams and PMO representatives as a process expert, trainer, and coach for the PDP and design control-related activities as well as support continuous improvement initiatives within the business to drive better execution and compliance of the PDP process. This role may. This role may also be responsible for representing the Product Development and Design Control processes in internal and external audits and inspections.
A Day in the Life
• Develops, implements, administers product development and design control compliance policies, procedures, and practices.
• Act as a key subject matter expert and critical point of contact on the phase gate project realization and design control process to the product development organization and within broader Medtronic forums and initiatives.
• Ensures alignment with legal and ethical standards of the organization.
• Provides product development, design control and compliance advice, investigates compliance problems, questions, or complaints and verifies deficiencies are corrected.
• Develops and delivers employee communication and training and coaching programs that focus on the elements of a companywide product development and compliance program.
• Analyzes trending and coordinates and/or prepares for internal and external audits of the functional compliance program.
• Maintains current knowledge of design control regulations including 820.30 and ISO 13485, and industry guidance and interpretation that impact the company's compliance program
Must Have: Minimum Requirements
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Additional Information