13 days old

Regulatory Affairs Director, RGI

Medtronic
Regulatory Affairs Director, RGI

Location:

United States

Requisition #:

19000H2K

Post Date:

Sep 03, 2019


**Careers that Change Lives**


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

+ Leads or compiles all materials required in submissions, license renewal and annual registrations.

+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

+ Monitors and improves tracking / control systems.

+ Keeps abreast of regulatory procedures and changes.

+ May direct interaction with regulatory agencies on defined matters.

+ Recommends strategies for earliest possible approvals of clinical trials applications.


**Must Have: Minimum Requirements**


Bachelors degree


Minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience


In depth knowledge of healthcare industry, environment and GPOs/IDNs


**Nice to Have**


Clinical experience as a physician


People leadershipexperience


Knowledge of U.S., European and International regulations and standards covering medical devices.


Experience with FDA and ISO audits, practical experience with ISO 13485, QSR, ISO9001.


Ability to influence others


Excellent interpersonal skills are a must to be effective in a matrix organization and with customers.


Excellent organizational and managerial skills Strong team player and mature personality that works effectively on cross-functional teams, with medical and non-medical professionals at all levels and in an international environment.


Excellent communication skills


Excellent change management skills


Strong project management, planning and organizational abilities


Computer proficiency with Excel, Word, PowerPoint, Outlook


Experience with analytical tools and dashboard generation


Excellent verbal and written English skills


**About Medtronic**


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.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**Physical Job 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 Day in the Life 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.


**EEO**


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
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.

Categories

Posted: 2019-09-05 Expires: 2019-10-12

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Affairs Director, RGI

Medtronic

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast