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Principal Regulatory Affairs Specialist - Neurovascular

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Regulatory Affairs
📅
200007YZ Requisition #

Principal Regulatory Affairs Specialist - RTG Neurovascular (Brain)


The Principal 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. The Principal RAS clearly communicates strategies to Regulatory Affairs (RA) management, project teams, and business unit leadership.  You will prepare regulatory filings for new products, as well as post market changes. As necessary, you will also review complex regulatory issues with RA management.
 


 
 

Responsibilities:

• Lead business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that the State of the Art requirements are maintained.
• Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to project teams and RA management. 
• Provide leadership to business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products.
• Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Lead preparation of FDA submissions and CE Mark Technical Files (MDD and MDR) for product changes and/or new products as required to ensure timely approvals for market released products.
• Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
• Assist in keeping company informed of regulatory requirements in the US and EU.
• Participate on Product Development teams by providing regulatory strategy, timelines, and direction.
• Prepare US and EU submissions.  Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.
• Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.
• Review labeling, training, promotional and advertising material.
• Support post market regulatory compliance activities for US/EU product approvals.
• Develop and maintain regulatory affairs department procedures and process improvements
• Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct
• Keep 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, strokes and aneurysms, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment.
Our efforts will have lasting impact on countless individuals and families — it is an opportunity we value and take pride in.

Medtronic Neurovascular is focused on creating life-saving devices to treat stroke. As part of the Brain Therapies Organization, we are revolutionizing how acute ischemic and hemorrhagic stroke is treated all over the world. We are focused on meeting our goal of no patient lost, no patient delayed, best patient outcome

Medtronic is a $30.6 Billion company with 90,000+ employees in more than 160 countries.

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.


 

Come for a job.  Stay for a career.


Must Have: Minimum Requirements (Must be evident on the resume)
• Bachelor's Degree required. 
• 7+ years of US/EU medical device regulatory experience with Bachelor’s degree (2 years of quality experience in medical device or a Master’s degree in Regulatory Affairs may substitute for up to 2 years of experience)
 

Preferred Qualifications:

• 510(k) or PMA submission experience
• Engineering or Advanced degree preferred
• Knowledge of FDA and EU requirements
• Degree in Engineering, Science, or Regulatory Affairs
• Strong communication skills
• Strong technical writing skills
• Regulatory Affairs Certification
• Master’s degree in Regulatory Affairs or Engineering
• PMA experience
• IDE experience
 

 
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 (<10% typically and no travel during the COVID-19 period)
 
 
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 offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, strokes and aneurysms, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment.
Our efforts will have lasting impact on countless individuals and families — it is an opportunity we value and take pride in.
Medtronic Neurovascular is focused on creating life-saving devices to treat stroke. As part of the Brain Therapies Organization, we are revolutionizing how acute ischemic and hemorrhagic stroke is treated all over the world. We are focused on meeting our goal of no patient lost, no patient delayed, best patient outcome
Medtronic is a $30.6 Billion company with 90,000+ employees in more than 160 countries.
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.
 
 
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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