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Medtronic, Inc.

Sr Regulatory Affairs Specialist - China

Medtronic, Inc. - Minneapolis, MN

Sr Regulatory Affairs Specialist - China

Medtronic

Minneapolis

MN

Job #663235832

Sr Regulatory Affairs Specialist - China

Location:

Fridley, Minnesota, United States

Requisition #:

180008OS

Post Date:

1 day ago

Senior Regulatory Affairs Specialist - China - RTG Neuromodulation

Careers that Change Lives

The Senior International Regulatory Affairs Specialist

is responsible for developing regulatory strategies, preparing international regulatory submission deliverables, and obtaining and maintaining approvals necessary to market Neuromodulation products and therapies in international markets. Specifically, the initial focus of this role will be China registrations but may include other geographies in the future. Works closely with in-country Regulatory colleagues to prepare agency submissions and with US Regulatory colleagues and other functional areas to provide timely responses to regulator questions in support of product approvals. Ensures all information provided to international colleagues is accurate, complete, and compliant to local requirements.

A Day in the Life / Responsibilities:

•Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products.

•Plan, coordinate, create, and provide deliverables to international colleagues to support new product registrations, license renewals, tender bids, and change submissions.

•Review documents required for submissions to international geographies to ensure they are appropriate for submission and meet local requirements.

•Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.

•Manage RAD/InSight database content to support new and on-going International requests. Maintain database to ensure deliverables are accurate and up to date to ensure International regulatory submissions are accurate and reflect current product configurations.

•Support document and site inspections by international auditors.

•Interpret new and changing international regulatory requirements, communicate impact to stakeholders, and develop implementation plans.

•Interface with governmental agency on projects/products as identified by the manager.

•Perform other related duties as assigned in support of international regulatory activities

•Ability to travel to China 1-2 times per year

•Ability for flexible work schedule due to interaction with colleagues in different time zones (must be able to attend early morning and late evening meetings)

Medtronic RTG (Restorative Therapies Group) Overview

The Restorative Therapies Group

develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

BRAIN MODULATION - Deep Brain Stimulation

include neurostimulators providing rechargeable deep brain stimulation and thin devices capable of delivering bilateral stimulation.

PAIN THERAPIES offer solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

SPINE THERARIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

BRAIN THERAPIES offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

SPECIALTY THERAPIES offer a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

Come for a job. Stay for a career.

Must Have: Minimum Requirements

•Fluent in English and Chinese (Written and Spoken).

•Bachelor’s degree.

•4 years of experience in the medical device industry with Bachelor’s degree

•2 years of experience in the medical device industry with Master's degree.

Preferred experience:

•Regulatory Affairs experience

•Understanding of engineering concepts, medical device development, anatomy, and medical practice

•Experience working with technical documentation

•Strong communication skills (written and verbal)

•Proven success managing multiple projects and priorities

•Attention to detail

•Advanced analytical thinking skills

•Ability to work with various cultures and personality types; enjoy working in team environment

•Proficient in Microsoft Word, Excel, and PowerPoint

Physical job 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. 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 is required to interact with a computer, and communicate with co-workers

RTG (Restorative Therapies Group) Overview

The Restorative Therapies Group

develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

BRAIN MODULATION - Deep Brain Stimulation include neurostimulators providing rechargeable deep brain stimulation and thin devices capable of delivering bilateral stimulation.

BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.

SPINE THERAPIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

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: ~~~

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.

Updated 05/13/2018

10 days 23 hours ago

Medtronic, Inc.

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Sr Regulatory Affairs Specialist - China Medtronic, Inc. - Minneapolis, MN, United States

   

Location: Minneapolis, MN

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.