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Senior Regulatory Affairs Specialist - Surgical

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Regulatory Affairs
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1900004G Requisition #
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Senior Regulatory Affairs Specialist - US/EU - Electronic Surgical Innovations Group 

 

 

Medtronic’s Surgical Innovations Group (ESG) has an exciting opportunity for a Sr. Regulatory Affairs Specialist on the dynamic team located in Boulder, CO.

 


Careers that Change Lives

 


The Senior Regulatory Affairs Specialist (Sr. RAS) will engage with New Product Development (NPD) teams to establish regulatory strategies, participate in creation and review of key product development deliverables, and author regulatory documents (e.g., 510(k)s and technical files).  As an NPD core team member, the Sr. RAS works directly with the NPD team from the concept phase through commercialization.  The Sr. RAS has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions around the world.

 

Sustaining regulatory responsibilities include review of products and labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, review of promotional materials, and ensuring that our product technical documentation is current and accurate.

 

 

The Sr. RAS will demonstrate following behaviors in their role:
• Manage multiple projects and prioritize tasks on a day by day basis to meet project schedules
• Use strong critical thinking skills to navigate the gray and to reach appropriate conclusions
• Work effectively with colleagues in many functional areas
• Apply excellent written and verbal skills to communicate internally and externally
• Demonstrate a continuous improvement mindset, always looking for ways to improve the ways we do our jobs

 


A Day in the Life  / Responsibilities:


• Establish and implement regulatory strategies for new technologies and product modifications, considering both domestic and international regulations
• Prepare 510(k) submissions and technical documents to support the CE mark and other international submissions
• Participate in preparation of IDE, PMA, or de novo reclassification submissions if needed
• Provide regulatory affairs support to design teams and sustaining engineering; this includes input into bench and pre-clinical test requirements
• Establish and maintain a professional and credible image with FDA, notified bodies, and other regulatory agencies
• Evaluate information on competitive technologies as needed to identify appropriate predicate or comparable devices to be included in 510(k)s and clinical evaluation reports
• Design History File documentation and adherence to FDA/QSR design control requirements
• Interface with engineering, clinical, sales, marketing, quality, and other functions as needed to fulfill responsibilities
• Review and approve marketing collateral
• Pay attention to detail and ensure completeness and accuracy in all regulatory documents
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits as needed
• Support international product registrations as needed
• Perform other duties as assigned

 

 

 

The Surgical Innovations Group, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience creating energy based surgical devices. Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient’s health into careful consideration.

 

This is a 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
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

 

Medtronic is a $29.7b company with 95,000+ employees in more than 160 countries.

 

Come for a job.  Stay for a career.


MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):

• Bachelor's Degree in scientific or engineering discipline
• 4+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s Degree.
• 2+ years of medical device experience, with work experience in regulatory affairs with Master’s Degree.
 
DESIRED/PREFERRED QUALIFICATIONS:
 
 
• Advanced degree and/or Regulatory Affairs Certification from RAPS
• Demonstrated successful history of submissions to FDA and notified bodies
• Working knowledge of IEC 60601-series standards
• Prior experience with software-driven devices
• Familiarity with regulatory requirements in major international markets
• Good understanding of design control requirements
• Experience with risk management
 
 
 
PHYSICAL 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.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
 
MITG Surgical Innovations Group Overview
 
The Surgical Innovations Group, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience creating energy based surgical devices. Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient’s health into careful consideration.
This is a 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
 
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
 
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
 
 
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.
 

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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