Principal Regulatory Affairs Specialist - Renal Care Solutions
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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.
Minimum Required Qualifications (Must be evident on your resume):
EDUCATION REQUIRED
• Bachelor's Degree in science, math, or engineering discipline. Advanced degree desired
• Bachelor's Degree in science, math, or engineering discipline. Advanced degree desired
YEARS OF EXPERIENCE
• 8+ years in the medical device industry with Regulatory Affairs experience with Bachelor’s Degree.
• 5+ years in the medical device industry with Regulatory Affairs experience and Master’s Degree.
• 5+ years in the medical device industry with Regulatory Affairs experience and Master’s Degree.
Desired/Preferred Qualifications:
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
• Experience with PMA, IDE, De Novo, and/or 510(k) product and submissions. 510(k) experience desired.
• Experience in supporting Class III device or IIb active medical device European Technical documentation and Submissions.
• Experience with Pharmaceutical or Combination product
• Highly proficient in spoken and written English.
• Experience with negotiations/interactions with regulatory agencies/health authorities is preferred.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Ability to work in matrix teams
• Strong organization and time management skills
• Demonstrated ability to influence based on experience, facts and data
• Highly motivated and results-oriented leader
• Project-management skills and experience
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Knowledge of Quality System requirements and FDA and/or International product approval process.
• Experience with PMA, IDE, De Novo, and/or 510(k) product and submissions. 510(k) experience desired.
• Experience in supporting Class III device or IIb active medical device European Technical documentation and Submissions.
• Experience with Pharmaceutical or Combination product
• Highly proficient in spoken and written English.
• Experience with negotiations/interactions with regulatory agencies/health authorities is preferred.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Ability to work in matrix teams
• Strong organization and time management skills
• Demonstrated ability to influence based on experience, facts and data
• Highly motivated and results-oriented leader
• Project-management skills and experience
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Knowledge of Quality System requirements and FDA and/or International product approval process.
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. 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.
• 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 - 20%), including International travel.
• 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 - 20%), including International travel.
MITG/ Renal Care Solutions (RCS) Overview
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
The Renal Care Support (RCS) Group, within the Minimally Invasive Therapies Group, brings together Medtronic and Covidien’s experience advancing renal care through innovative design. Dialysis presents a unique set of challenges. Vascular access is critical to treatment and vulnerable to clotting and infection, some of the leading causes of catheter failure. We are leading the way by providing clinical solutions. Our acute, chronic and peritoneal dialysis catheters are designed to improve flow rates, reduce the risk of clotting, increase patient comfort and provide ease of use for clinicians. Our catheters help you meet the clinical demands of treating patients who need hemodialysis, apheresis, infusion, central venous pressure monitoring and high-pressure contrast injection.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
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.
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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