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Sr Regulatory Affairs Specialist International

📁
Regulatory Affairs
📅
19000JQY Requisition #

Senior Regulatory Affairs Specialist - International - Neurovascular

 


The Senior Regulatory Affairs Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within the domestic and International markets. In this role, you will ensure compliance with relevant FDA, MDD, ISO and other global regulations, for neurovascular products. You will support local RA to interact with regulatory authorities to assure timely new product introductions and continued product access. You will work on PMA activity and participate on internal development teams, providing US and/or International regulatory strategy and execution. You will lead and execute complex regulatory projects. The Senior International Regulatory Affairs Specialist will provide regulatory review of labeling and advertising, design changes, and specification changes.


Responsibilities:

 

• Develop US and International 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, providing regulatory strategy, timelines, and direction
• Prepare US submissions and International submissions. Work with FDA to obtain product approval/clearance
• Ensure relevant ISO and FDA Export requirements are met, as required
• Support product shipping release.
• Support local RA team with government queries and registration documentation requirements.
• Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions per standard procedures
• Review labeling, training, promotional and advertising material
• Evaluate post-market incident reports and determine MDR requirements
• Support post market regulatory compliance activities for US/International product approvals
• Develop and maintain regulatory affairs department procedures
• Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct
• May travel : 10-20%


 

 

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/Neurovascular 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 in science, engineering, or healthcare related field.
• 4+ years of US and International medical device submission experience and/or regulatory affairs experience
• Knowledge of FDA, EU, MHLW, Canada and TGA requirements
 

Preferred Qualifications:
 
• US FDA 510(k) and EU submission experience
• Working knowledge of global regulatory submissions
• Regulatory Affairs Certification
• Advanced degree preferred
• Strong communication skills
• Strong technical writing skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Strong organization and time management skills
 
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 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.  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)
• 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%)
 
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/Neurovascular 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.
 
 
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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