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Medtronic, Inc.

Sr Regulatory Affairs Specialist (Diabetes Group)

Medtronic, Inc. - Northridge, CA

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Location:

Northridge

CA

Date:

12/05/2017

2017-12-05

2018-01-03

Job Code:

37324

Categories:

Engineering

Legal

Manufacturing / Production

Healthcare

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Job Details

Job Details

Company

Medtronic

Job Title

Sr Regulatory Affairs Specialist (Diabetes Group)

JobId

37324

Location:

Northridge, CA, 91325, USA

Description

Sr Regulatory Affairs Specialist (Diabetes Group)

Location:

Northridge, California, United States

Requisition #:

17000L3L

Post Date:

1 day ago

**Sr Regulatory Affairs Specialist(Diabetes Group)**

**Location: Northridge, CA**

**Careers That Change Lives**

We’re a

mission-driven leader in medical technology and solutions with a legacy of

integrity and innovation. Join our team in Regulatory Affairs and help shape

policies that change lives.

The Sr Regulatory Affairs Specialist is

responsible for developing regulatory strategy, preparing U.S. and

international submissions and obtaining approval to introduce Medtronic

products and therapies to markets worldwide.

The Diabetes Group is working with the

global community to change the way people manage diabetes. Together, we will

transform diabetes care by expanding access, integrating care, and improving

outcomes, so people with diabetes can enjoy greater freedom and better health.

We value what makes you unique. Be a part of a

company that thinks differently to solve problems, make progress, and deliver

meaningful innovations.

We value what makes you unique. Be a part of a

company that thinks differently to solve problems, make progress, and deliver

meaningful innovations.

Visit www.medtronicdiabetes.com to see an overview

of the products in our Diabetes product portfolio.

**A Day in the Life**

• Team with business unit Regulatory

Affairs Specialists (RAS) and international regulatory staffs to provide

regulatory support for new products/therapies and changes to existing products.

Work with RAS, engineers and technical experts to resolve potential regulatory

issues and questions from regulatory agencies.

• Prepare FDA submissions for new

products and product changes as required to ensure timely approvals and market

release. Review only significant submission decisions/content issues with

manager; negotiate submission issues with agency personnel.

• Provide support for

currently-marketed products. This includes reviewing product/manufacturing

process changes, supplier changes, new and revised engineering protocols and

reports, and product labeling.

• Coordinate product dossiers and

technical files for Medtronic products.

• Participate in project meetings and

provide feedback to product development teams on regulatory issues and

questions.

• Maintain proficiency in worldwide

regulatory requirements; monitor changes to regulatory requirements and

communicating this information to departments within the business unit that may

be affected by these changes; establish and maintain good relationships with

agency personnel.

• Monitor and interpret latest FDA

regulatory environment and assess impact to new product development projects

and existing business procedures and practice.

• Review and Revise SOPs, and other

company and departmental procedures to ensure quality system compliance.

• Perform other duties as assigned.

• Travel up to 10%

**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirementsare evident on your resume.**

Bachelor’s degree with 4 years of workexperience or Master’s degree with 2 years of work experience

Experience in a regulatory function/rolewithin the healthcare industry

Experience in creating/writing/developing/preparingregulatory submissions

**Nice to Have**

Master’sDegree or Doctorate in Regulatory Affairs and Regulatory Affairs Certification(RAC)

Experiencein developing and preparing regulatory submissions (i.e. Premarket Approval(PMA) for Class II and/or Class III medical devices; for Diabetes-relatedmedical devices)

Thoroughknowledge of medical device product development and design control

Previousinvolvement in presentations to FDA Advisory Panels

**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. Let’s 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.

Ability to

travel up to 10%

**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 at http://www.uscis.gov/e-verify/employees :// at http://www.uscis.gov/e-verify/employees www.uscis.gov/e-verify/employees

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8 days 11 hours ago

Medtronic, Inc.

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Sr Regulatory Affairs Specialist (Diabetes Group) Medtronic, Inc. - Northridge, CA, United States

   

Location: Northridge, CA

Company Profile:
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Group’s products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.