Regulatory Affairs Specialist - Vascular products

Medtronic Inc. Santa Rosa, CA
Regulatory Affairs Specialist - CVG

Careers that Change Lives

The Regulatory Affairs Specialist will provide worldwide regulatory affairs support for Class II and Class III medical devices. The Regulatory Affairs Specialist is responsible for activities that lead to, and maintain regulatory approval for these medical devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implanting these device changes. This position typically reports to the Regulatory Affairs Manager.

A Day in the Life / Responsibilities:

* Participates in preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

* Compiles all materials required in submissions, license renewal and annual registrations.

* 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.

* Prepares global regulatory submissions such as original IDE, original PMA and 510(k) submissions and supplements, EU Design Dossiers and Technical Files, Canadian Device License Applications, and Japanese Shonins.

* Develops global regulatory strategies to seek approvals for new and modified devices worldwide. Monitor emerging regulatory trends and integrate new requirements into department procedures and toolkits.

* Provides regulatory support to currently marketed products, as necessary. Assesses product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required by classification and geography.

* Reviews device labeling, advertising, sales support and training materials for compliance with submissions and applicable regulations.

* Provides regulatory support to product manufacturing transfers. Provides regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes. Provides statistical support and bridging between Clinical and Data Management/Biostatistics team members. Implements regulatory aspects of Field Actions

* Provides regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis. Provides regulatory input to the company for compliance with ISO, Japan, and FDA Quality System Regulation requirements.

* Provides input for clinical studies to assure compliance with domestic and international regulatory requirements (GCP), as well as to ensure efficient and approvable study designs

* Assists Manager in negotiations with the FDA or other regulatory agencies for assigned projects.

* Obtains and distributes updated information regarding worldwide laws, guidelines, and standards. Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities.

* Develops and delivers presentations to worldwide regulatory agencies. Topics may include submission strategies, technical and statistical approaches, compliance issues or new initiatives. Assist in developing and maintaining positive relationships with device reviewers through oral and written communications.

* Participates in training and mentoring of staff.

* Other tasks, as assigned.

Medtronic CVG (Cardiac and Vascular Group) Overview

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one 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. This group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products.

Come for a job. Stay for a career.

Must Have: Minimum Requirements

* Bachelor's degree.

* 2+ years of experience in medical device regulatory affairs, quality, or engineering with Bachelor's degree

* 1+ years of experience in medical device regulatory affairs, quality, or engineering with engineering degree or Master's degree.

Preferred experience:

* History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

* Strong negotiation skills and written/oral communication skills

* Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines

* Strong organizational skills and time management skills

* Experience with regulatory support of clinical trials.

* Previous experience supporting manufacturing and design changes

* Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

* Previous experience with document management systems and change control systems.

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

CVG (Cardiac and Vascular Group) Overview

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one 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. This group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products.

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: 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.

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