Senior Regulatory Affairs Specialist

Chemence • Alpharetta, GA

10h • Onsite

About The Position

Under general supervision, the Senior Regulatory Affairs Specialist is an expert in a specific field of study responsible for liaising with other departments to lead efforts to update systems and processes in compliance with guidelines or regulations that govern Chemence Medical products. The Senior Regulatory Affairs Specialist will also assist the organization in training, implementation and preparation for new or updated standards, guidance and regulations (e.g. 21 CFR 820, ISO 13485, EU MDR and MDSAP). The Senior Regulatory Affairs Specialist will serve as the project lead for successful implementation of systems, processes and training programs.

Requirements

• Bachelor’s degree (or higher) in scientific or engineering discipline
• 8+ years of related industry experience
• Expert in specific guidance, standard or area (e.g. Auditing, EU MDR, Clinical Studies)
• Excellent English verbal and written communication skills
• Strong analytical and organizational skills with the ability to multi-task and prioritize competing demands
• Computer skills with proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat

Nice To Haves

• bilingual (Spanish) a plus

Responsibilities

• Implement new projects or programs at Chemence Medical to comply with newly implemented or changes to existing regulations.
• Assists with managing Global registrations and Economic Operators.
• Perform scientific and technical analyses on medical devices during early product development to assess compliance requirements.
• Updates PMS, GSPRs, PMCF and Essential Principal documents as needed.
• Assess changes to marketed devices, determine effects on regulatory global regulatory status, and perform resulting regulatory activities.
• Research regulatory and industry changes that may impact global regulatory operations and reports to teams for evaluation.
• Prepare adverse event reports in accordance with applicable regulations.
• Provides audit support during FDA, ISO and Notified Body Audits and Corporate.
• May perform other duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior