Sr Regulatory Affairs Specialist, Coronary - Santa Rosa, CA
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MUST HAVE - MINIMUM REQUIREMENTS:
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
Minimum Education required:
- Bachelor's degree
Years of Experience Required:
- Minimum of 4 years regulatory affairs or other relevant experience with Bachelors
- Minimum of 2 years regulatory affairs or other relevant experience with Masters
NICE TO HAVE:
- Direct experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA), and working with cross-functional project teams. Sound understanding of basic Design Controls, Software Life Cycle, Risk Management, and Verification & Validation processes
- In depth experience with FDA requirements, guidance documents, IDE, PMA, 510(k) submissions, Medical Device Directive, ISO 14971, ISO 13485, IEC 60601, IEC 62366, IEC 62304, and other global regulatory requirements and quality standards. Knowledge of new Medical Device Regulations (MDR).
- Ability to work in a matrixed organization and geographically diverse business environment
- 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
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Proficient in MS applications (Excel, Word, Outlook)
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 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.
- The employee is required to be independently mobile
- The employee must be able to travel independently to various Medtronic buildings/sites.
- The employee is required to interact with a computer, and communicate with co-workers
- The employee is required to travel by car and by airplane (approx.10%), including possible International travel
