Senior Regulatory Affairs Specialist – Premarket (Medtronic Diabetes Group)
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.
Careers that Change Lives
The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for developing regulatory strategy, preparing U.S. and EU submissions and obtaining approval to introduce new Medtronic products and therapies to markets worldwide.
The Sr. RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.
This role focuses on regulatory support for the US, EU, and Global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. 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 world’s leading medical device company
A Day in the Life / Responsibilities:
- 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.
• Prepare FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.
• Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
• Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, export certificates, and establishment registrations and device listings.
• May interact directly with FDA 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.
• 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
- Bachelor’s Degree
- Minimum 4 years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
- Minimum 2 years of regulatory experience in medical device, biotech, or pharmaceutical industry with an advanced degree.
Nice To Have
- Bachelor’s in Engineering, Science, Regulatory Affairs
- Master’s Degree in Regulatory Science
- Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, drug or biologics submissions)
- History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
- Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews
- Experience with regulatory support of clinical trials
- Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
- Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
- Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports. IVD device experience is preferred.
- Regulatory Affairs Certification (RAC)
- Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
- Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
- Ability to compile data and summarize results
- 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
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. Let’s 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).
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Job posted: 2020-07-09