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Sr Regulatory Affairs Specialist

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Regulatory Affairs
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19000H3W Requisition #

Senior Regulatory Affairs Specialist - RTG Neurovascular


 
The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe.  This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes.

 

 

Responsibilities:

 

• Participate on project teams, providing regulatory strategy, timelines, and deliverables
• Prepare US and EU submissions.  Work with FDA, Notified Body, and regulatory geography support to obtain product approval/clearance.
• Develop US and International regulatory strategies and timelines for product submissions; identifying needs for bench, animal and clinical testing
• Review Change Orders and assess regulatory impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures
• Review labeling and assess compliance against relevant regulations and product requirements
• Develop and maintain regulatory affairs department procedures and process improvements
• Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct
• Assist in keeping company informed of regulatory requirements in the US and EU.

 

 

The Restorative Therapies Group (RTG) 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 offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

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.
 

Come for a job.  Stay for a career.

Must Have: Minimum Requirements (Must be evident on the resume)
 
• Bachelor’s Degree
• 4+ years of US/EU medical device regulatory submission experience with Bachelor’s degree or 2+ years of US/EU medical device regulatory submission experience with Master’s degree
• Knowledge of FDA and EU requirements

 

Preferred Qualifications:
 
• 510(k) or PMA submission experience
• Strong communication skills
• Strong technical writing skills
• Regulatory Affairs Certification
 
 
 
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
 
Physical Requirements:
 
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
The physical demands described within the Position 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. 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).  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 must be able to travel independently to various Medtronic buildings/sites.
• The employee is required to interact with a computer, and communicate with co-workers
• The employee is required to travel by car and by airplane (<20%), including possible International travel
 
 
RTG (Restorative Therapies Group) Overview

The Restorative Therapies Group (RTG) 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 improve the precision and workflow of neuro procedures.
 
 
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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