1+ months

Senior Principal Regulatory Affair Specialist - Pre Market MDIS (Medtronic Diabetes Group)

Medtronic
Northridge, CA 91325
Senior Principal Regulatory Affair Specialist - Pre Market MDIS (Medtronic Diabetes Group)

Location:

Northridge, California, United States

Requisition #:

210004AR

Post Date:

Feb 17, 2021


**SENIOR PRINCIPAL REGULATORY AFFAIRS SPECIALIST - PRE MARKET MDIS (MEDTRONIC DIABETES GROUP)**


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


The Medtronic Diabetes Group offers an integrated system combining our MiniMed Insulin Pump Therapy with our Continuous Glucose Monitoring systems. The Multiple Daily Injection Solutions (MDIS **)** group will focus on defining and executing our full CGM portfolio. We are 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.


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.


**Careers That Change Lives**


As **Sr. Principal Regulatory Affairs Specialist** , you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.This role focuses on products with software and/or interoperability with other devices or external networks. In this role, you will have primary RA responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the worlds leading medical device company.


**A Day In The Life**


+ Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

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

+ Prepare regulatory (eg, FDA/Notified Body) submissions for new products and product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.

+ Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.

+ Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.

+ Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

+ Apply software and security (i.e., cybersecurity) regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products.

+ Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

+ Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

+ Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

+ Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.

+ Provide regulatory input to product lifecycle planning.

+ Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.

+ Provide feedback and on-going support to product development teams for regulatory issues and questions.

+ Ensure personal understanding of all quality policy/system items that are personally applicable.

+ Follow all work/quality procedures to ensure quality system compliance and high-quality work

+ Other duties as assigned.


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Requires a University Degree and minimum of 10 years of medical device regulatory experience, or advanced degree with a minimum of 8 years of medical device regulatory experience


**Nice to Have**


+ Experience in Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, including IDE and software-containing devices.

+ Prior direct involvement with product development teams

+ Working knowledge of IEC 60601-series standards

+ Software-related regulatory experience required (e.g., IEC62304, FDA Software/Cybersecurity Guidance Documents)

+ Prior experience with software-driven devices

+ Familiarity with regulatory requirements in major international markets Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations

+ Regulatory Affairs Certification (RAC)

+ Experience in assembling facts from various areas, analyzing data, and providing informed recommendations

+ Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.

+ Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.

+ Ability to compile data and summarize results

+ Proficiency in FDA compliance.

+ Organized, efficient, process-oriented; high attention to detail

+ Effective interpersonal/communication skills

+ Works well under pressure in a dynamic timeline-driven environment

+ Ability to effectively manage multiple projects and priorities

+ Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills


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


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. For Office Roles: 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. 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)


A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.


Learn more about our benefits: benefits.medtronic.com


This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .
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: 2021-02-19 Expires: 2021-05-29

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Senior Principal Regulatory Affair Specialist - Pre Market MDIS (Medtronic Diabetes Group)

Medtronic
Northridge, CA 91325

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