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Principal Regulatory Affairs Specialist

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Regulatory Affairs
📅
19000H3Y Requisition #

Principal Regulatory Affairs Specialist - Neuro


The Principal Regulatory Affairs Specialist (Prin RAS) is responsible for developing regulatory strategy, preparing U.S. and EU submissions and obtaining approval for Medtronic products and therapies to markets worldwide.

The Prin RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates approval with regulatory agencies as required.  Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. 

 

This role focuses on regulatory support for the US, EU, and Global 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:

 

• Lead preparation of FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.
• Provide leadership with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
• Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, export certificates, and establishment registrations and device listings.
• Represent RA function for EU MDR, including leading and prioritizing technical documentation requirements
• May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Ensure personal understanding of all quality policy/system items that are personally applicable. 
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• 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.
 
BRAIN THERAPIES NEURO GROUP 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.

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 
7+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
5+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Master’s degree.

• Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, drug or biologics submissions)
 
 
Preferred Qualifications:
 
• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances. 
• Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews
• Experience with regulatory support of clinical trials
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
• Product experience with neurological devices, combination devices, laser and laser annual reporting requirements, Electromagnetic Compatibility (EMC), Implantable devices and thorough knowledge of regulatory requirements
• Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.
• Regulatory Affairs Certification (RAC)
• Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
• Ability to compile data and summarize results
• Organized, efficient, process-oriented; high attention to detail
• Effective interpersonal/communication skills
• Works well under pressure in a dynamic timeline-driven environment
• Ability to effectively manage multiple projects and priorities
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software 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 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%)
 
 
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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