Principal Regulatory Operation Specialist
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About Medtronic
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)
Must Have; Minimum Requirements
- Bachelor’s Degree
- Minimum 7 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Bachelor’s degree.
- Or minimum 5 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Master’s degree.
Nice To Have
- Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry
- Experience with Internet/Intranet technology and interactive software applications such as SharePoint and InfoPath.
- Advanced to expert level knowledge and use of Microsoft Office Suite applications, Outlook, Word, Adobe Acrobat, and Excel,
- Ability to quickly learn new computer technology software packages with minimal training
- Experience working with technical documentation and design dossiers.
- Analytical and problem-solving skills associated with software and complex documents, including the ability to detect, troubleshoot and rectify routine issues with systems.
- Expertise on general records management and archiving strategies and capturing metrics.
- Expert project management skills; ability to efficiently manage multiple projects and priorities, including meticulous attention to detail and the ability to complete multiple simultaneous assignments within a given period of time and with minimal supervision.
- Excellent written and verbal communication skills
- Strong customer service skills to interact with individuals at various levels of the organization and external contacts when necessary.
- Ability to work with established procedures and to establish processes and procedures as needed, including the ability to understand policies and procedures necessary when working in a regulated environment.
- Motivated self-starter with the ability to perform independently or in teams in a fast-paced environment in response to business-critical assignments.
- Experience with GTS licensing and UDI coordination and knowledge of EU MDR.
About Medtronic
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)
