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Regulatory Affairs Specialist - Advocacy Software & Cybersecurity (Diabetes Group)

Medtronic
Northridge, CA 91325
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Regulatory Affairs Specialist - Advocacy Software & Cybersecurity (Diabetes Group)

Location:

Northridge, California, United States

Requisition #:

220003FS

Post Date:

Mar 23, 2022


**REGULATORY AFFAIRS SPECIALIST - ADVOCACY SOFTWARE CYBERSECURITY - DIABETES**


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 Automated Delivery System (ADS **)** group will focus on defining and executing our closed loop. 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.


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


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 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.


**Careers That Change Lives**


The **Regulatory Affairs Specialist Advocacy Software Cybersecurity** position sits in the Innovation Pillar of the organization and is charged with leading the development and execution of innovative global regulatory strategies for next generation Diabetes devices. These strategies will require in-depth understanding of all aspects of the digital health regulatory environment, ranging from artificial intelligence and SaMD to cybersecurity. In this role, you will work in a heavily matrixed environment consisting of specialists from every aspect of the device lifecycle. Your work will empower the use of software best practices by developing and advocating for the best regulatory strategy to meet the needs of our patients and our business partners.


Your work will be focused on digital health regulatory topics that are rapidly evolving and its intersection with our products and processes. This intersectionality provides an excellent entry point for those with experience in other areas of the medical device space who are looking to evolve their careers, including those with backgrounds in device advocacy, systems engineering, software architecture, cybersecurity, and/or quality assurance. This position is best suited for professionals desiring to develop their career in creative software device innovation and digital health advocacy at the worlds leading medical device company.


**A Day In The Life**


+ You will primarily focus on developing and refining fit-for-purpose regulatory strategies to support the digital health innovations of the Diabetes business in early phases of development with stakeholders across the businessUS, EU, international regulatory teams as well as from various partner functions such as quality assurance and RD.

+ Maintain proficiency of worldwide regulatory intelligence on digital health and cybersecurity including competitor filings as part of developing innovative regulatory strategies. Establish and maintain good relationships with agency personnel and allies in industry and advocacy groups.

+ Deliver and/or manage projects assigned to support business improvement initiatives around digital health and cybersecurity issues. Work with other stakeholders to provide oversight of regulatory strategy and work with subject matter experts across the business or within regulatory to resolve potential regulatory issues and questions that may arise from regulatory agencies to achieve desired results. All significant issues will be reviewed with the manager.

+ Provide strategic input for preparation of submission packages (e.g. PMAs, 510k, Technical file dossiers, international submissions, etc.). Acts as a resource for colleagues as a subject matter expert in digital health and cybersecurity for late phase projects and sustaining regulatory activities.

+ Review of supporting documentation (e.g., labeling, design verification, clinical study design, etc.) to assure alignment with global regulatory strategy.

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

+ Other duties as assigned.

+ Remote work option available.

+ Ability to travel, up to 10%, as business and local policies allow.


**Must Have; Minimum Requirements**


+ Bachelors Degree (Engineering or scientific discipline, such as biology, chemistry or physics)

+ Minumum 2years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelors degree.

+ Or 0 years of experience with an advanced degree


**Nice To Have**


+ 2+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Masters degree.

+ Masters Degree or Doctorate in scientific/engineering fields and related medical device-oriented disciplines (e.g. Regulatory Affairs)

+ Technically savvy: must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical / logistical issues

+ Clear communicator, able to break down highly technical information with stakeholders of various backgrounds and functional responsibilities to find a common understanding.

+ Critical thinking and creative problem solving

+ Experience with technical presentations and/or education sessions

+ Able to participate effectively in multiple workstreams with different goals and expectations. Capable of meeting the needs of teams in a timeline-dependent environment

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

+ Product experience with software medical devices and quality systems

+ Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards

+ Experience with regulatory submissions, such as IDEs, Original PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files, 30-day Notices, and Real Time Reviews

+ Regulatory Affairs Certification (RAC)

+ Professional skill level with writing and presentation tools, such as Microsoft Word, Excel, Office, PowerPoint, and Adobe software


**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)
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: 2022-03-25 Expires: 2022-06-03
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Regulatory Affairs Specialist - Advocacy Software & Cybersecurity (Diabetes Group)

Medtronic
Northridge, CA 91325

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