Regulatory Affairs Operations Specialist - Neurosurgery
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RTG (Restorative Therapies Group) Overview
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.
EEO STATEMENT:
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Must Have: Minimum Requirements
• Bachelor’s degree.
• 2+ years of experience in regulatory affairs, quality, or engineering with Bachelor’s degree
• 1+ years of experience in regulatory affairs, quality, or engineering with Master's degree.
• 2+ years of experience in regulatory affairs, quality, or engineering with Bachelor’s degree
• 1+ years of experience in regulatory affairs, quality, or engineering with Master's degree.
Preferred experience:
• Demonstrated experience in preparing 510(k) submissions for FDA. Other worldwide submissions a plus.
• Computer literacy, proficiency in MS Word, Excel, PowerPoint, Adobe Professional, etc.
• High learning aptitude and adaptability with software systems
• Previous experience with document management systems and change control systems.
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Strong written/oral communication skills
• Strong organizational skills and time management skills
• Highly self-motivated
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
• Ability to manage small scale projects to completion within and outside
• Previous experience supporting manufacturing and design changes a plus
• Experience with Class III devices are a plus
• Computer literacy, proficiency in MS Word, Excel, PowerPoint, Adobe Professional, etc.
• High learning aptitude and adaptability with software systems
• Previous experience with document management systems and change control systems.
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Strong written/oral communication skills
• Strong organizational skills and time management skills
• Highly self-motivated
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
• Ability to manage small scale projects to completion within and outside
• Previous experience supporting manufacturing and design changes a plus
• Experience with Class III devices are a plus
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.
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers
RTG (Restorative Therapies Group) Overview
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.
BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.
SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
SPINE THERAPIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
SPINE THERAPIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
EEO STATEMENT:
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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