Regulatory Affairs Manager

ASO Worldwide; Sarasota (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

ASO Worldwide is seeking a Regulatory Affairs Manager to lead regulatory and compliance activities ensuring FDA and global regulatory adherence, including ISO 13485 alignment and QMS support.

The role requires extensive experience in FDA-regulated devices, knowledge of MDR/UDI, and strategies for regulatory submissions across regions. Strong communication and organizational skills are essential for cross-functional collaboration and audits.

Qualifications

• Bachelor's degree in Quality, Regulatory Affairs or an applicable science.
• Master's degree preferred.
• Minimum 7+ years of regulatory experience in an FDA-regulated industry.
• Understanding of ISO 13485 and MDSAP.

Responsibilities

• Works with internal stakeholders, regulatory agencies/bodies, and consultants 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 to meet ISO 13485 standards.
• Confirms FDA product codes under 21 CFR for new products and assists with regulatory requirements for launches.
• Develops and maintains regulatory reports and records for ASO products.
• Proposes regulatory submission strategies in support of business plans.
• Reviews claims and product labeling for ASO products.
• Responsible for classification review of new and existing commercial products, raw materials, and imported materials.
• Maintains product regulatory files/records and compliance documentation.
• Keeps regulatory knowledge current and communicates changes through policies and procedures.
• Recommends changes to procedures in response to regulatory updates.
• Performs regulatory risk assessments and initiates projects as needed.
• Develops regulatory networks with regulatory bodies, consultants, and legal entities across regions.
• Supports internal and external audits.
• Other duties as assigned.

Skills

Regulatory knowledge

Communication skills

MS Office

ERP/MRP systems

Organizational skills

Attention to detail

Education

Bachelor's degree in Quality/Regulatory Affairs or Engineering

Master's degree preferred

Job description

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.

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 (both written and verbal), 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.