Regulatory Affairs Specialist

Together, we can change healthcare worldwide. At Medtronic, We push the limits of what technology 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.
 
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one 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. 

A day in the Life

Leads or compiles all materials required in submissions, license renewal and annual registrations.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Monitors and improves tracking / control systems.

Keeps abreast of regulatory procedures and changes.

May direct interaction with regulatory agencies on defined matters.

Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

2+ years w/ Bachelor’s degree or 0+ years w/Master’s degree experience in Regulatory Affairs, Engineering, Quality or Clinical

Nice to Have:

• Working knowledge of global medical device regulations, including submissions. 
• Demonstrated writing/technical writing skills.
• Demonstrated Microsoft Word, Excel and Adobe software skills.
• Experience in or exposure to combination devices.
• Experience in or exposure to pharmaceutical regulations.
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Effective verbal and written communication skills.
• Effective organizational skills.
• Experience with solving problems and concerns.
• Attention to detail.
• Effective negotiating skills.
• Experience with project management and adherence to time schedules.
• Quality or Regulatory compliance experience or background.
• Self-motived 
• Work well under pressure in a dynamic environment.
• Ability to audit own work to ensure compliance.

Type

Corporate / junior

North America

Santa Ana , United States

Location

United States

Santa Ana

Type

Corporate / junior