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Sr Regulatory Affairs Specialist

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Regulatory Affairs
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1900017B Requisition #
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Senior Regulatory Affairs Specialist - US/EU Respiratory Monitoring

 

 
Careers that Change Lives

 

 

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

 
 

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 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 Patient Monitoring Group, within MITG, provides decades of experience across areas of respiratory care, we offer unmatched clinical and economic value through our range of market-leading brands.

 

Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient's health into careful consideration. 

 

Patient safety and positive outcomes drive our innovation. That’s why we collaborate with leading patient monitoring and medical device manufacturers to deliver vital parameter technologies — which provide clinicians the real-time information they need to rapidly assess patient status and proactively determine the most appropriate treatment for each unique patient.

 

For decades, medical device companies have trusted our Patient Monitoring Solutions to provide clinicians these market-leading parameter technologies for monitoring respiratory status (oxygenation and ventilation), as well as end-organ perfusion and function.

 

Our Patient Monitoring Solutions are available in a wide variety of flexible platforms and are backed by a global team of clinical, engineering, and marketing professionals. With our personalized and collaborative process for successfully integrating Medtronic Monitoring Solutions, you get more than advanced technology — you get a partnership with people you know and trust.

 

Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient's health into careful consideration. 

 

 

 

Come for a job.  Stay for a career.

Must Have: Minimum Requirements
 
• Bachelor’s degree.
• 4+ years of medical device experience with experience in regulatory affairs or quality assurance with a Bachelor's degree
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• 2+ years regulatory submission experience.
 
 
Preferred experience:
 

• RAPS Certification (RAC)
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (AIMD and MDD).
• Experience with medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).
• 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 job 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.
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers
 
 
Respiratory Monitoring Group, within MITG
 
Patient safety and positive outcomes drive our innovation. That’s why we collaborate with leading patient monitoring and medical device manufacturers to deliver vital parameter technologies — which provide clinicians the real-time information they need to rapidly assess patient status and proactively determine the most appropriate treatment for each unique patient.
 
For decades, medical device companies have trusted our Patient Monitoring Solutions to provide clinicians these market-leading parameter technologies for monitoring respiratory status (oxygenation and ventilation), as well as end-organ perfusion and function.
 
Our Patient Monitoring Solutions are available in a wide variety of flexible platforms and are backed by a global team of clinical, engineering, and marketing professionals. With our personalized and collaborative process for successfully integrating Medtronic Monitoring Solutions, you get more than advanced technology — you get a partnership with people you know and trust.
Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient's health into careful consideration. 
The Vital Sync™ monitoring and CDS solution integrates information from wearable and bedside devices and transmits it to a hospital server. This single software platform helps clinicians gain more value from their medical devices. The Vital Sync™ CDS solution allows clinicians to take action with immediate access to smart, actionable data, implement clinical protocols through use of CDS apps, view patient physiological information remotely, and receive updates and alerts on any web-enabled device.

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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