Regulatory Affairs Manager

Aso,-LLC; Florida; Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Aso,-LLC seeks a Regulatory Affairs Manager to lead regulatory and compliance directives across our product portfolio, ensuring FDA and other authorities adherence and supporting the Quality Management System.

The role focuses on coordinating with regulatory bodies, managing risk assessments, and developing submission strategies while maintaining regulatory documentation and relationships with external consultants.

Qualifications

• 7+ years of regulatory experience in FDA-regulated industry.
• Knowledge of 510K, NDA, ANDA, and OTC guidelines.
• Understanding of ISO 13485, MDR, UDI, labeling and change control requirements.

Responsabilités

• Lead regulatory and compliance initiatives across ASO products.
• Serve as primary PRRC for Europe and Health Canada coordination.
• Support Quality System in line with ISO 13485.
• Develop regulatory submission strategies and maintain regulatory files.
• Review labeling and claims for ASO products.
• Maintain regulatory knowledge base and communicate changes to policies.

Connaissances

Excellent communication

MS Office/Outlook

MRP/ERP systems

Regulatory thinking

Organized/self-starter

Formation

Bachelor's degree in Quality/Regulatory Affairs

Master's degree preferred

Outils

MRP/ERP systems

Description du poste

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Regulatory Affairs Manager

Active - Salary full-time Management Sarasota, FL, US

9 days ago Requisition ID: 1207

General Summary

The Regulatory Affairs Manager will be responsible for leading ASO's Regulatory and Compliance directives carrying out a wide range of initiatives while ensuring compliance to FDA and other regulatory bodies/entities in addition ensuring adherence to the Quality Management System.

Key Responsibilities

• Works with internal stakeholders, regulatory agencies/bodies, and consultants as required to ensure product-specific regulatory compliance.
• Manages Regulatory Risk Assessments per ISO 14971.
• Acts as the main primary Person Responsible for Regulatory Compliance for Europe (PRRC) and Health Canada (HC).
• Supports Quality System as needed meeting ISO 13485 standards.
• Confirms FDA product codes under 21 CFR for new products and assisting with assessment of regulatory requirements for launching new products.
• Develops and maintains appropriate reports from regulatory and compliance perspective.
• Proposes regulatory submission strategies in support of business strategies.
• Reviews claims and product labeling for all ASO product.
• Responds to customer issues, questions and concerns related to ASO product.
• Responsible for classification review of new commercial products, existing commercial products upon regulatory change, raw materials, all imported materials, etc.
• Creates and maintains product regulatory files/ records relating to ASO products.
• Stays abreast and interpret regulatory codes, rules or code changes and ensure that they are communicated through corporate policies and procedures. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Recommends changes to company procedures in response to changes in regulations or standards.
• Performs and maintains a regulatory risk assessment and provide timely recommendations and projects related to the company
• Develops and maintains regulatory network (formal and informal) by establishing relationships with various regulatory bodies, local consultants and legal entities within the respective countries / regions where ASO has business interests.
• Supports internal and external audits
• Other duties as assigned

Qualifications

To perform this job successfully, an individual should be able to perform each essential duty / key responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability preferred. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education

Bachelor's degree in Quality, Regulatory Affairs or an applicable science (Engineering) required. Masters preferred.

Experience

Minimum of 7+ years of Regulatory experience within an FDA regulated industry. Understanding of Regulatory requirements for Medical Devices under ISO 13485 MDSAP. Understanding of 510K, NDA, ANDA, and OTC guidelines is required. Medical Device Reporting (MDR). UDI requirements. Labeling regulations. Design controls. Risk management (ISO 14971). Clinical evaluation requirements. Change control and post-market surveillance.

Skills & Abilities

Must possess excellent communication skills, and enjoy working with a diverse customer/employee base. Candidate should be proficient in the use of computer systems including MS Office and Outlook. Previous use of MRP/ERP systems and/or other databases and knowledge of manufacturing organization structure, policies, and procedures and a plus. Candidate must be able to deal with high intensity situations involving problems with multiple variables in a wide range of situations. Must be highly organized, a self-starter, able to prioritize and carry out multiple functions simultaneously.