You may not recognize our name, but you know our products. Over the past 65 years, ASO has become the market leader in producing high-quality consumer wound and health care products which are now the preferred choice for consumers in the USA and abroad. ASO products are primarily sold under the brand name of mass merchandisers, food & grocery retailers, drug store chains, as well as distributors in professional medical markets. ASO has partnered with these retailers to provide high quality products with innovative brand strategies which build store brand value, increase returns, and enhance market share in the categories of products we provide. In 2014, ASO was selected as Wal*Mart’s supplier of the year besting all other branded companies and private label suppliers in the health and beauty care category. Our success is directly attributable to ASO’s talented employees who innovate, create and support the highest quality products within our marketplace at the best possible price and value for the consumer. We are currently seeking to hire a skilled Regulatory Affairs Manager to join our talented team. 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. Support 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. Respond 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. Recommend changes to company procedures in response to change in regulations or standards. Perform and maintain a regulatory risk assessment and provide timely recommendations and projects related to the company Develop and maintain regulatory network (formal and informal) by establishing relationship with various regulatory bodies, local consultants and legal entities within the respective countries / regions where ASO has business interests Performs other related and assigned duties by senior management 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 accommodations 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 preferred. Experience: Minimum of 5+ years of Regulatory experience within an FDA regulated industry. Understanding of Regulatory requirements for Medical Devices under ISO 13485. Understanding of 510K, NDA, ANDA, and OTC guidelines is required. Skills & Abilities: Should 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 should be able to deal with high intensity situations involving problems with multiple variables in a wide range of situations. Should be highly organized, a self-starter, able to prioritize and carry out multiple functions simultaneously.