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Position Summary:
This position is a subject matter expert in global medical device labeling, regulations and requirements and is responsible for planning, developing and executing labeling documentation and product labeling. The Specialist will ensure adherence to company policy and procedures and will assist in maintaining quality control processes. This position will help EXALTA Group maximize the amount of patients served while maintaining a high level of quality and safety through the support of the business functions.Â
Responsibilities:Â
- Develops, edits, reviews and processes labeling documentation and medical device labeling following company procedures, including translation management. Labeling documentation and labeling to include product labels, instructions for use (IFUs), patient leaflets, implant cards, summary of safety and clinical performance (SSCPs), etc.
- Ensures labeling documentation and labeling is professional, readable and compliant with applicable global regulations, directives, standards and guidance requirements.Â
- Works with cross functional project teams to perform GTIN allocation.
- Assist with GUDID and EUDAMED data maintenance and submissions.
- Investigate and resolve internal audit findings and external audit findings related to labeling non-conformities.
- Support internal and external audits specific to labeling processes and released labeling documentation and labels.
- Monitor global labeling regulations, directives, standards and guidance requirements for changes in labeling requirements, perform gap assessments where required.
- Write and update standard operating procedures and work instructions to maintain compliance with applicable labeling regulations, directives, guidance, and standards.Â
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Core Competencies:
- Medical Terminology
- Strong understanding of regulations and guidelines related to medical devices and quality systems including: 21 CFR 820; MDD 93/42/EEC; MDR 2017/745; and ISO 13485
- Excellent communication skills, both written and oral
- Strong computer skills, project management skills, problem solving skills, and a high attention to detail
- Ability to work under pressure and with cross-functional teamsÂ
- Project management skills
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Education/Experience Required:
- Minimum of 2 years experience in regulatory affairs or quality systems
- BA/BS in scientific discipline or equivalent experience
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