Regulatory Affairs Specialist - Clinical Focus
Must Have; Minimum Requirements
- Bachelor’s Degree (Scientific discipline, such as biology, chemistry or physics; clinical research; or Engineering)
- Minimum 2+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
- Or 0 years of regulatory experience with an advanced degree.
Nice To Have
- Master’s Degree or Doctorate in Regulatory Affairs, Clinical Research, or Scientific discipline
- Experience in drafting IDEs, Competent Authority submissions for clinical study, IRB or Ethics Committee submissions
- Experience with regulatory support of clinical trials
- Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
- Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
- Able to assess changes against regulatory guidance’s and determine 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
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. 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)
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.