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Regulatory Affairs Specialist - Electrosurgical US EU

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Regulatory Affairs
📅
19000KRM Requisition #

Regulatory Affairs Specialist - RTG Electrosurgical Release Product Engineering



The Regulatory Affairs Specialist will develop strategies for worldwide regulatory approval to introduce product changes to market, including labeling, manufacturing, and design changes.  Preparing U.S and E.U. assessments as well as associated Regulatory documentation.  Work may include US and EU submissions and negotiating their approval.   Products include complex systems with clinical software, accessories and instrumentation.

 

This role focuses on regulatory support for the US, EU, and Canadian markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

 

From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.
 

Responsibilities:

• Follow all Quality System Practices and SOP’s as defined by Medtronic  policies, practices and procedures to ensure that FDA’s Quality System Regulation, ISO 13485, MDD, MHLW, CMDR and all other applicable regulations are met.
• Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company and sector.  Interpret new and existing regulatory requirements as they relate to the products and initiate actions to assure compliance to these regulations.
• Provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release.
• Provide support to market-released products. This includes reviewing labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval.
• Perform submission activities for devices in gaining required clearances through the processes of IDE’s, 510(k)s, CE marking and other world-wide approval requirements as necessary.
• Perform new and on-going reviews of marketing materials, go-to-market strategies and other commercialization activities as required to insure continued compliance to established product clearances; lead the development of regulatory strategies for new claims, indications and therapies.
• Prepare submissions and reports for FDA and support other international agencies as required by product status.
• Work with other departments to support CAPA investigations, root cause determinations, situation analyses, risk evaluations and regulatory assessments.
• Manage field corrective action plans and associated regulatory body notifications.
• Provide regulatory support for internal and external audits performed on Medtronic Navigation quality systems
• Approve accept with concessions dispositions for nonconforming product based on product and regulation knowledge as well as critical thinking.
• Perform all activities in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned

 

 

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.

 

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
• 2+ years of regulatory affairs experience in the medical device industry with Bachelor’s degree
• 0+ years of regulatory affairs experience in the medical device industry with Master’s degree
 
 
Preferred Qualifications:
• Experience with medical device regulatory submissions.
• Experience with FDA, ISO, QSR, or EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions.
• Experience in marketing materials review and the maintenance of compliant commercialization strategies.
• Experience in electro-mechanical medical devices.
• Experience with biocompatibility testing and sterilization validation preferred.
• Experience with international medical device consensus standards preferred.
• Good presentation skills.
• Excellent oral and written communication skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Ability to work in a team environment and exert influence without alienating others.
• Ability to work independently when required with minimal management oversight.
• Able to work within established guidelines and have flexibility as to method, priority and timing of job duties.
• This position requires a significant amount of initiative and judgment.

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
 
 
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.
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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