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Customer Support Analyst, 100% Remote

Company: TEKsystems, Inc
Location: Loveland
Posted on: January 12, 2021

Job Description:

IMMEDIATE & MULTIPLE Regulatory Project Leader openings with global healthcare company seeking candidates with IVD and Medical Device experience! Actively interviewing regulatory affairs candidates to support their long term project!Description:MUST HAVE:1. IVD (Invitro Diagnostics) experience2. Experience authoring 510k submissions3. BA degree requiredJob Description:* Working on the Polaris Project* Mainly Domestic US based, individual contributor (no direct reports).* Authoring 510ks* Ensuring all the regulatory documentations are reviewed and delivered on time* Working with project management team and other core depts* Assists In Definition/Implementation Of Regulatory Strategy And Priorities In Conjunction With Management, Peers, Commercial, And Affiliate Personnel.* Responsible For Writing And Timely Completion Of Regulatory Strategies And Issues, Scientific Substantiation For Product Claims, And Label/Promotional Material Activities.* Responsible For Effective Communication Of Regulatory Requirements To Project Teams And Internal CustomersExperience: Skills: Demonstrated experience clearing devices in US Duties: * Communicates issues to management through project management tracking and issue briefings.* Position is highly visible to internal stakeholders. High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.* Prior regulatory experience with IVDs or medical devices is required. Experience with CLIA waived products is a plus.* Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.* Ability to communicate effectively in writing crisp briefings and issue analysis.* Demonstrated ability to work effectively in a team environment. Responsible for writing and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.* Responsible for effective communication of regulatory requirements to project teams and internal customersTop Skills:IVD, in vitro diagnostics, regulatory affairs, 510kTop Skills Details:MUST HAVE:1. IVD (Invitro Diagnostics) experience2. Experience authoring 510k submissions3. BA degree requiredAdditional Skills & Qualifications:Education: Bachelor's degree required, Masters degree preferred Experience: Minimum of 6 years experience Regulatory Affairs***Position is 100% Remote - can be located in any time zone, needs to be flexible to work EST. (that is where a majority of the team sits).About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing-- Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: TEKsystems, Inc, Loveland , Customer Support Analyst, 100% Remote, Professions , Loveland, Colorado

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