Kelly · 20 hours ago

Regulatory Affairs Specialist

Alpharetta, GA

Full-time

Remote

Entry Level

$24/hr - $24/hr

3+ years exp

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No H1B

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Responsibilities

Assisting the contracts and sales team during new product development and design control processes, reporting to the Manager of Regulatory Affairs.

Reviewing labeling and Copy & Claims requests for compliance with internal procedures and FDA requirements.

Coordinating activities necessary to ensure global regulatory compliance with FDA, Canadian, European, and other agency regulations.

Qualification

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Regulatory AffairsMedical Device IndustryFDA ComplianceISO RegulationsBiological SciencesMicrobiologyChemistryCommunication with AgenciesRegulatory ComplianceAudit PracticesGraduate Studies in Regulatory Affairs

Required

Hold a Bachelor’s degree in biological sciences, microbiology, chemistry, or engineering

Have 3+ years of experience in Regulatory Affairs, preferably in a medical device company, with experience communicating with regulatory agencies

Possess a working knowledge of ISO and applicable international regulations, compliance, and audit practices

Preferred

Graduate studies in Regulatory Affairs are preferred

Benefits

Medical/Dental/Vision/Life Insurance

8 Paid Holidays

3 weeks of PTO

401K

Weekly pay

Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability

Retirement savings plan

Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)

Transit spending account

Paid sick leave under the applicable state or local plan