1+ months

Regulatory Operations Specialist Minimally Invasive Surgical

Medtronic
North Haven, CT 06473
Regulatory Operations Specialist Minimally Invasive Surgical

Location:

North Haven, Connecticut, United States

Requisition #:

19000NZY

Post Date:

Dec 03, 2019


**REGULATORY AFFAIRS OPERATIONS SPECIALIST**


The **Regulatory Affairs Operations Specialist** supports the MITG RA Ops team in the organization, analysis, reporting, implementation and maintenance of MITG RA data, systems, and processes. This position will provide support to the MITG RA Groups during integration efforts and in MITG wide project where RA information is required to scope, plan, and assess impacts on product registrations. Additionally, this position will work closely with RA Ops Manager to establish processes within MITG to support global change notification, RA data adequacy, certificate of analysis, FDA Establishment Registration, RA reporting, and RA system usage, including training. This position will also focus on continuous improvement of RA processes, systems and documents across Medtronic to drive standardization and automation. The improvements require the position to create alignment, more consistent practices, and build partnerships across regulatory and other functions as needed.


**Responsibilities/A Day In The Life:**


Responsible to support QARA Ops Management in the development, implementation, and maintenance of QARA systems and processes. This includes but is not limited to:

Lead the implementation of system associated to Product Data Management for global registration management (InSight/RAD), product change notification (PCN) and Certificate of Analysis (CoA);

Provide technical support on QARA systems and processes;

Support the MITG global RA assessment of product change notification (PCN) using the Agile system;

Support the MITG US/EU registration data entry in InSight;

Support the FDA Establishment registration process at MITG;

Develop and deploy new processes, templates and training within QARA;

Support MITG Business Unit in the organization and supply of RA data for GTS, Insight, PCN, and UDI (MDM) requirements;

Support of MITG Business Units in issue resolution that arise from data and process inconsistencies in RA Systems;

Maintain current regulatory databases and systems and produce various reports as needed;

Create and maintain up to date MITG QARA procedures;

Maintain and provide regulatory information in support of MITG wide initiatives for general scoping and planning for the BU RA teams;

Improve regulatory intelligence by attending regulatory seminars and meetings.


The **Minimally Invasive Therapies Group (MITG)** aspires to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive solutions. We help patients get better faster with fewer complications across all care settings. Our innovative therapies developed in partnership with healthcare professionals treat nearly 70 major patient conditions. They're used across the care continuum from diagnosis to recovery in a variety of specialties and procedures, and include:


Surgical technologies and instruments used in open surgery and minimally invasive surgery (MIS)

Devices that monitor patients during and after surgery

Technologies that allow doctors to monitor patients remotely

Equipment that supports and monitors patients breathing


Together, our solutions enable less invasive, more successful patient care with earlier diagnosis, better treatment, and faster, complication-free recovery.


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:**


Medtronic is a $30.5b company with 90,000+ employees in more than 160 countries.


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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**Must Have: Minimum Requirements**


Bachelors degree required

Minimum 2 years of regulatory affairs submittal or regulatory operations experience

OR Advanced degree with 0 years of experience


**Preferred:**


Regulatory or quality experience in medical device industry.

General knowledge of industry practices, techniques and standards.

Experience in regulatory affairs, either in regulatory product specialist role or regulatory operations role.

High attention to detail, highly skilled in task management, task oriented.

Records and Data Management

Microsoft applications, which includes working with templates, and editing and formatting complex documents.

Proficiency in Excel with ability to convert data for more effective analysis.

Working knowledge and/or experience working in InSight, Agile or other related system.

Excellent communication skills (written and verbal).

Strong critical thinking and analytical skills.

Experience with Internet/Intranet technology, SharePoint, and other interactive software applications.

Agility to manage changing priorities, responsibilities, and timelines.

Effective organizational skills and attention to detail.

Strong work ethic.

Works well under pressure in a dynamic environment.


**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 (5%)


**MEDTRONIC MINIMALLY INVASIVE THERAPIES GROUP (MITG)**


The **Minimally Invasive Therapies Group (MITG)** aspires to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive solutions. We help patients get better faster with fewer complications across all care settings. Our innovative therapies developed in partnership with healthcare professionals treat nearly 70 major patient conditions. They're used across the care continuum from diagnosis to recovery in a variety of specialties and procedures, and include:


Surgical technologies and instruments used in open surgery and minimally invasive surgery (MIS)

Devices that monitor patients during and after surgery

Technologies that allow doctors to monitor patients remotely

Equipment that supports and monitors patients breathing


Together, our solutions enable less invasive, more successful patient care with earlier diagnosis, better treatment, and faster, complication-free recovery.

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**

Medtronic is a $30.5b company with 90,000+ employees in more than 160 countries.


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Whatever your specialty or ambitions, you can make a difference at Medtronic both in the lives of others and your career.


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. Lets 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.


**_Come for a job. Stay for a career._**
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: 2019-12-05 Expires: 2020-02-09

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Regulatory Operations Specialist Minimally Invasive Surgical

Medtronic
North Haven, CT 06473

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