Regulatory Labeling Associate
Regenity Biosciences, Paramus, NJ, United States
Position Summary
The Regulatory Associate - Labeling is responsible for preparing labeling in compliance with applicable regulations, guidance, company procedures and customer requirements; maintains accurate records and submits product/labeling data to relevant government agencies. Interacts with project teams, customers, vendors and regulators for labeling development and implementation. Essential Job Functions
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (i.e. FDA, MDR, MDD, ISO, EN, etc.) with respect to labeling and unique identifier requirements. Coordinate with customers, suppliers, and project teams to prepare compliant labeling to support global regulatory submissions, registrations, and filings. Duties include label design, approval, and label implementation. Provide professional customer service to ensure customer requirements are met, communicate regarding pending labeling changes and the status of label implementation. Assign GTIN numbers, maintain product and UDI lists, and support data entry to the Global Unique Device Identification Database (GUDID), EUDAMED, and other global databases, as appropriate. Ensure current labeling is uploaded to relevant websites. Complete gap analysis to ensure continued compliance with updated regulations and standards and recommend changes to company quality system procedures. Compile and maintain regulatory documentation databases or systems. Document and file Regulatory Status Determinations for assessment of labeling changes. Ensure proper notification and/or approval of labeling changes for impacted jurisdictions. Participate in internal or external audits. Assist with various special ad‑hoc projects and other duties as assigned. Competencies
Determination Integrity Creativity Collaboration Moved by Urgency Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. Education, Experience, and Certifications
Ability to follow written and oral instructions with minimum supervision. Good organizational ability and strong attention to detail. Ability to utilize computer application packages, such as MS Word, Excel, and Adobe. Good communication skills, both verbal and written. Bachelor's Degree, Associate’s Degree or equivalent experience. Experience in a related field a plus. Other Duties as Required
Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties, and responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice. Total Rewards & Benefits
Company performance bonus eligibility 401(k) plan with company contribution Paid time off and paid holidays Medical, prescription, dental, and vision insurance Company‑paid life and AD&D insurance Wellness Program and Employee Assistance Program (EAP) Tuition Reimbursement Salary Range: $45,000 – $60,000 per year Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.
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The Regulatory Associate - Labeling is responsible for preparing labeling in compliance with applicable regulations, guidance, company procedures and customer requirements; maintains accurate records and submits product/labeling data to relevant government agencies. Interacts with project teams, customers, vendors and regulators for labeling development and implementation. Essential Job Functions
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents (i.e. FDA, MDR, MDD, ISO, EN, etc.) with respect to labeling and unique identifier requirements. Coordinate with customers, suppliers, and project teams to prepare compliant labeling to support global regulatory submissions, registrations, and filings. Duties include label design, approval, and label implementation. Provide professional customer service to ensure customer requirements are met, communicate regarding pending labeling changes and the status of label implementation. Assign GTIN numbers, maintain product and UDI lists, and support data entry to the Global Unique Device Identification Database (GUDID), EUDAMED, and other global databases, as appropriate. Ensure current labeling is uploaded to relevant websites. Complete gap analysis to ensure continued compliance with updated regulations and standards and recommend changes to company quality system procedures. Compile and maintain regulatory documentation databases or systems. Document and file Regulatory Status Determinations for assessment of labeling changes. Ensure proper notification and/or approval of labeling changes for impacted jurisdictions. Participate in internal or external audits. Assist with various special ad‑hoc projects and other duties as assigned. Competencies
Determination Integrity Creativity Collaboration Moved by Urgency Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. Education, Experience, and Certifications
Ability to follow written and oral instructions with minimum supervision. Good organizational ability and strong attention to detail. Ability to utilize computer application packages, such as MS Word, Excel, and Adobe. Good communication skills, both verbal and written. Bachelor's Degree, Associate’s Degree or equivalent experience. Experience in a related field a plus. Other Duties as Required
Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties, and responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice. Total Rewards & Benefits
Company performance bonus eligibility 401(k) plan with company contribution Paid time off and paid holidays Medical, prescription, dental, and vision insurance Company‑paid life and AD&D insurance Wellness Program and Employee Assistance Program (EAP) Tuition Reimbursement Salary Range: $45,000 – $60,000 per year Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.
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