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Sr Regulatory Affairs Specialist

📁
Regulatory Affairs
📅
19000J8K Requisition #

Senior Regulatory Affairs Specialist - US/EU  

 
The Senior Regulatory Affairs Specialist is responsible for regulatory submission activities as well as maintaining of existing approved products and providing provide global pre- and post-market support.
 

Senior Regulatory Affairs Specialist will be part of our dynamic team located in Boulder, CO.

 


Careers that Change Lives


A Day in the Life  / Responsibilities:

 

• Team with 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.
• Prepare 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.
• 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. 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.


 

The Surgical Innovations Group, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience creating energy based surgical devices. Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient’s health into careful consideration.


 

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.


MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):

• Bachelor's Degree
• 4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelor’s Degree.
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
 
 
DESIRED/PREFERRED QUALIFICATIONS:
• 4+ years regulatory submission experience.
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
• Experience with medical devices (510(k))
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Project management skills.
• Product development experience.
• Knowledge of Medtronic procedures and systems.
• Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
• Strong oral and written communication skills.
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient skills with MS Word, MS Outlook, MS Excel.
 
 
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.
• While performing the duties of this job, the employee is regularly required to be independently mobile. 
• The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
 
 
MITG Surgical Innovations Group Overview
 
The Surgical Innovations Group, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience creating energy based surgical devices. Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient’s health into careful consideration.
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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