Medtronic Principal Compliance/Audit Specialist in Mystic, Connecticut
Principal Compliance/Audit Specialist
Jacksonville, Florida, United States
Dec 11, 2020
Careers That Change Lives
In this exciting role as a Principal Compliance Audit Specialist , you will have primary focus responsibility to implement the RTG Internal Audit schedule.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Coordinates and/or completes internal/external risk assessments and/or audits in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
May counsel stakeholders about these requirements as necessary.
Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.
Travel requirements: 35%
Must Have: Minimum Requirements
Bachelorsdegree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+years of work experience in Quality or regulated industry.
Nice to Have: (Preferred Qualifications)
Experience in Quality/Compliance and/or Audit with medical device requirements (e.g. MDSAP, EU MDR, ISO 13485)
Experience auditing Quality Systems to global requirements
Quality System Lead Auditor certified
Specialized expertise (Sterilization, microbiology, medical device software, combination products, active medical devices, EPRC, radiation emitting devices, robotics)
Prior FDA or NB auditor experience
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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.