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Description: 

• Completes a variety of administrative tasks for Regulatory project support which may include but is not limited to document formatting, document generation, document storage coordination and shipping of regulatory submissions.
• Manage multiple deliverables including project planning and creation of action plans, tracking of bowlers, escalation communication, stakeholder management and Daily Management.
• Works cross-functionally on specific projects as they arise (for example with R&D and/or QA).

Required Skills/Experience:

• 1-3 years of RA experience required.
• High School Diploma or equivalent required.
• Associate or bachelors Degree preferred in science or related.
• IVD Regulatory Affairs or Quality Assurance experience is very beneficial and highly desirable.

Competencies:

• Excellent MS Word and MS Excel skills, Strong, independent worker capable of operating in a fast-paced, constantly changing environment.
• A self-starter able to manage their own workload and prioritize tasks accordingly.
• Must be results oriented with excellent organizational and time management skills.
• Excellent attention to detail. Must possess strong interpersonal and communication skills.
• Travel % of Travel, including approximate overnight stays per week.
• Travel expectations within this role are limited and flexible (<10%)

Additional Job Details:

Required Skills/Experience:

• 1-3 years of RA experience required.
• High School Diploma or equivalent required.
• Associate or bachelors Degree preferred in science or related.

Softpath System, LLC is an Affirmative Action /Equal Opportunity Employer