Assoc Regulatory Affairs Spec
Minimum Education Bachelor Degree
Educational: Science, Engineering, Business Administration or related field
Associate or Level 1: 0 Years with Diploma/ Degree
• Exposure to compliance, configuration, documentation, quality systems, quality engineering, auditing, laboratory or regulatory manufacturing environment
• Interpersonal Relations
• Quality and Results Oriented
• Computer Literate
• Fluency speaking and writing in English and Spanish
• Experience in medical device, pharmaceutical, or electronic industry
• Experience in Qualification / Validation activities.
• Experience and Certification in Auditing
- Problem Solving
- Teamwork
- Communications
- Continues Improvement
- Project Management
- Root Cause Analysis
- Technical Writing and Composition
- US Class I, II and III manufacturing process change Regulatory Impact Assessment Experience
- OUS Impact assessment to notify manufacturing process changes
- FDA 510 (k) Class II and PMA Class III Internal documentation report requirements knowledge
Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document.
Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment.
Work is performed in building’s interior with normal temperature, good illumination, air condition, clean environment and minimum risk
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)
