Senior Regulatory Affairs Specialist
BA and/or BS degree with 4+ years experience working in regulated, biotechnology environment
YEARS OF EXPERIENCE:
• Minimum of 4 years regulatory affairs with Bachelors
• Minimum of 2 years regulatory affairs experience with Masters
• Minimum of 0 year(s) experience with Doctorate
*Relevant experience is equal to those listed in the Minimum Requirements above.
Nice to Have
• In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, ISO 14971, ISO 13485, IEC 60601 and other global regulatory requirements and quality standards. Knowledge of new Medical Device Regulations (MDR).
• History of successful device submissions
• Knowledge of GLP/GCP requirements
• Strong negotiation skills and written/oral communication skills
• Strong organizational skills and time management skills
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Ablity to work independently and under general direction only
• Computer skills; MS Office, , Adobe Acrobat,
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
