28 days old

Regulatory Affairs Specialist Spine products

Medtronic
Memphis, TN 38111
Regulatory Affairs Specialist Spine products

Location:

Memphis, Tennessee, United States

Requisition #:

19000M1N

Post Date:

Nov 11, 2019


**Regulatory Affairs Specialist Spine Products**


The **Regulatory Affairs Specialist** will coordinate, author, prepare, and update technical document packages for domestic and international spinal medical device regulatory submissions, including 510(k)s and technical files, for new and existing products according to regulatory requirements and standards. You will interact with cross-functional counterparts, including engineers, microbiologists, and others. This role is responsible for communicating regulatory requirements for new and existing products to cross-functional partners, and review documentation for compliance. You will ensure regulatory compliance through the design process for new products, conduct regulatory assessments for, and author regulatory documentation to support changes to product design, labeling, packaging, or manufacturing process.


**Responsibilities**


Develop global regulatory strategies for medical device product submissions.

Participate as the regulatory representative on teams, providing regulatory strategy, timelines, and direction.

Assess documentation for compliance with regulatory requirements.

Assist in keeping company informed of global regulatory requirements.

Organize, prepare, and post international submissions and supporting documents. Work with regional counterparts to obtain product approvals and product renewals.

Review product changes in collaboration with the other specialists and assess regulatory impact of product changes on domestic and international markets. Provide documentation to geographies that require a submission or amendment.

Support review of labeling, training, promotional and advertising material.

Support post market regulatory compliance activities for global product approvals.

Develop and maintain regulatory affairs department procedures.

Comply with applicable global regulatory laws/standards and Company policies and procedures.

Work within the department and cross-functionally to resolve potential regulatory issues and questions from regulatory agencies or internal sources.

Keeps abreast of regulatory procedures and changes

May direct interaction with regulatory agencies on defined matters.


**Spine Orthopedic Therapy Group**


Medtronic is a world leader in spinal and musculoskeletal therapies. The Spine Orthopedic Therapies Group (within Restorative Therapies RTG)provides spinal fusion and artificial disc products from Medtronic, including bone graft options and minimally invasive spinal surgery options for patients.


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.


**_Come for a job. Stay for a career._**


**Minimum Required Qualifications (Must be evident on your resume):**


Bachelor's Degree in Engineering, Life Sciences, or related medical/scientific area of focus. Advanced degree preferred

2+ years of experience in the medical device industry with Bachelors degree

OR

Masters degree in Engineering, Life Sciences, Regulatory or related medical/scientific field with no experience


**Desired/Preferred Qualifications:**


Experience with medical device regulatory submissions (US and/or International)

Understanding of engineering concepts and scientific terminology

Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales

Experience reviewing technical and design specifications

Experience in medical device industry

Superior interpersonal skills

Excellent communication skills, both oral and written

Proven ability to prioritize, conduct, and manage time to meet project deadlines

Documented evidence of writing skills

Basic understanding of computer applications

Familiarity with medical terminology a plus

Some overnight travel required


**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%), including International travel.


**Spine Orthopedic Therapies Group**


Medtronic is a world leader in spinal and musculoskeletal therapies. The Spine Orthopedic Therapies Group (within Restorative Therapies RTG)provides spinal fusion and artificial disc products from Medtronic, including bone graft options and minimally invasive spinal surgery options for patients.


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. 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.

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Posted: 2019-11-14 Expires: 2019-12-21

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Regulatory Affairs Specialist Spine products

Medtronic
Memphis, TN 38111

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