Senior Regulatory Affairs Specialist (Sr. RAS) - US/EU - Diabetes Sustaining
The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for developing regulatory strategy, preparing and EU submissions and obtaining approval to ensure the continued regulatory compliance of existing Medtronic products and therapies on markets worldwide.
The roles focuses on regulatory support for the US and EU markets, as the RAS reviews product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling, and determines the impact on existing approvals. 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 and developing regulatory strategy, 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.
- Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for on-market products.
- Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- 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.
- Review product changes
- Manages submission activities for a variety of device regulatory approvals including the CE mark change notifications, US PMA supplements, 510(k)s, post-approval reports, annual reports, 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
The Medtronic Diabetes Group offers an integrated system combining our MiniMed Insulin Pump Therapy with our Continuous Glucose Monitoring systems. This group will focus on Premarket Sensors. 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.
Come for a job. Stay for a career.
MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
- Bachelor's Degree in chemistry, scientific or engineering discipline
- 4+ years of work experience in regulatory affairs with Bachelor's Degree in medical device, biotech, or pharmaceutical industry
- 2+ years of work experience in regulatory affairs with Master's Degree in medical device, biotech, or pharmaceutical industry
- 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, PMA supplements, drug or biologics submissions)
- History of successful 510(k)/IDE/PMA device/supplement submissions and other worldwide submissions and clearances.
- 2+ years of experience in healthcare industry (i.e. medical device,IVD pharma/drugs, biologics, biotech)
- Expertise in 30-Day Notices and RTRs, Design Dossiers, and Technical Files
- 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.
- Regulatory Affairs Certification (RAC)
- 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
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.
- 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.(