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Principal Regulatory Affairs Specialist Ventilators

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Regulatory Affairs
📅
200005R7 Requisition #

Principal Regulatory Affairs Specialist - Ventilators

 

 

The Principal Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals.  You will prepare comprehensive regulatory strategies for new devices and post market changes.  Clearly communicate strategies to Regulatory Affairs (RA) management, project teams, and business unit leadership.  Prepare regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management.


 

Responsibilities:

 

 

• Leads RGI business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that the State of the Art requirements are maintained.
• Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to project teams and RA management. 
• Provides leadership to 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.
• Leads preparation of 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. Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.  Establish and maintain good relationships with Agency personnel.
• Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD and MDR requirements, ISO 13485 and ISO 14155, China NMPA, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall MITG/RGI priorities globally.
• Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect.
• 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.
• As needed, you will represent Medtronic MITG/RGI in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body.
• Mentor and coach Medtronic MITG/RGI regulatory professionals in their development.

 

 

Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology, therapies and services 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.

 

The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions


 

RESPIRATORY, GASTROINTESTINAL & INFORMATICS (RGI) offers a complete line of solutions that spans the continuum of care.  We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.

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. 

 

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

 

Medtronic is a $30.5Billion 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.  Engineering or Advanced degree desired
• 7+ years of medical device experience with Regulatory Affairs experience with Bachelor’s Degree/5+ years of medical device experience with Regulatory Affairs experience with Master’s degree
 
 
Preferred Qualifications:
 
 
• 7+ years of regulatory submission experience.
• 510(k) submissions experience
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• First line experience with US FDA, China NMPA and EU MDD is required.
• Understands the requirements surrounding EU MDR requirements.
• Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements.
• Experiences surrounding international regulatory submissions and registrations is required.
• Must have experience with successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
• Proven 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.
 

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%), including possible International travel
 
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 $30.5 Billion company with 90,000+ employees in more than 160 countries.

 
 
The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions

 
RESPIRATORY, GASTROINTESTINAL & INFORMATICS (RGI) offers a complete line of solutions that spans the continuum of care.  We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.
 
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.

 
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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