Air Clean Systems

Air Clean Systems is a manufacturing company with 51-200 employees. The company currently has three open positions. Air Clean Systems is currently hiring for three roles: * **Senior Chemist:** This on-site position within the Science department reports to the Director of Laboratory Operations. The Senior Chemist will be responsible for developing and overseeing the chemistry aspects of projects and assays to support the development of current and future medical devices and products. Job duties include research and development, leading product development projects, developing new scientific methods and assays, improving and customizing current products, formulations and analytical methods and processes, creating and writing validations, test protocols, procedures, reports, and proposals, reviewing and evaluating analysis data, reviewing and evaluating scientific methods, procedures, data, and articles/journals, determining the relationships of chemical and physical properties, composition, structures and reactions of compounds using chromatography, spectrophotometry and spectroscopy techniques, performing applied scientific analysis and activities, operation of Liquid Chromatography instrumentation (HPLC), staying current and complying with various regulatory agencies, maintaining equipment, supplies, and chemicals, and ensuring health and safety within the laboratory. * **Buyer:** This on-site position's department or division is Purchasing and reports to the Director of Procurement. The Buyer is responsible for working with a minimum of direction or supervision to accomplish all the duties delegated by the Director of Procurement. The Buyer is responsible for knowing the accepted business purchasing methods and purchasing policies and procedures of the organization. * **Regulatory Affairs Specialist:** This on-site position within the Regulatory Affairs department reports to the Director of QA and RA. The Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on EU MDR technical file submissions. The Regulatory Affairs Specialist will help CS Medical navigate the industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance in the EU, working closely with healthcare regulatory bodies globally. The job duties include authoring EU MDR technical files and contributing to other international regulatory submissions, participating in strategic product development and design solutions, acting as a regulatory Subject Matter Expert (SME), monitoring global regulatory landscapes, and communicating new and coming changes. Air Clean Systems uses the following technologies: * **Senior Chemist:** Chemistry, Biochemistry, HPLC, Product Development, Analytical Skills, Sample Extraction, Bioanalytical Methods, Spectrophotometry, Chromatography, Quality Assurance, Good Laboratory Practices, Scientific Analysis, Project Management, Regulatory Compliance, Communication, Detail Oriented, Independent Work. * **Buyer:** Purchasing Methods, Negotiation, Supplier Evaluation, Contract Management, Order Management, Discrepancy Resolution, Market Knowledge, Documentation, Communication, Industry Trends, Product Knowledge, Cost Analysis, Inventory Management, Relationship Management, Problem Solving, Decision Making. * **Regulatory Affairs Specialist:** Regulatory Affairs, EU MDR, Technical Files, FDA, Health Canada, ISO 13485:2016, ISO 14971:2019, Documentation Skills, Communication Skills, Stakeholder Management, Software Development Lifecycle, Regulatory Compliance, Project Management, Strategic Guidance, Product Development, Cross-Functional Collaboration. Air Clean Systems has on-site positions available. The Regulatory Affairs Specialist position will work in office and warehouse environments. The general hours for the Regulatory Affairs Specialist position are Monday – Friday, 8:00am to 5:00pm with an hour break for lunch. Here are some frequently asked questions about working at Air Clean Systems, based on the job descriptions provided: 1. **Where are these positions located?** All open positions are based in Creedmoor, NC. 2. **What are the minimum qualifications for the Senior Chemist position?** The Senior Chemist position requires a B.S. or B.A. in Chemistry, Biochemistry or a related discipline, a minimum of five years of experience in a chemistry or related laboratory, a minimum of five years with HPLC work and development of assays, a minimum of five years of product development, the ability to lead projects, experience working in a laboratory setting, analytical skills, sample extraction and analysis, titrations, experience with bioanalytical methods, HPLC, spectrophotometry, the ability to interpret analysis from outside sources, PC skills, the ability to effectively communicate and interact with technical staff, being detail and quality oriented, the ability to work independently, willingness to travel in the US occasionally, and a working knowledge of Quality Assurance and Good Laboratory Practices. 3. **What are the responsibilities of the Buyer?** The Buyer is responsible for working with a minimum of direction or supervision to accomplish all the duties delegated by the Director of Procurement, knowing the accepted business purchasing methods and purchasing policies and procedures, and evaluating suppliers by considering price, quality, availability and other criteria. 4. **What are the responsibilities of the Regulatory Affairs Specialist?** The Regulatory Affairs Specialist is responsible for developing and executing the regulatory strategy, with a primary focus on EU MDR technical file submissions. 5. **What degree is required for the Regulatory Affairs Specialist position?** A minimum of a Bachelor's Degree is required. 6. **What benefits are offered to the Regulatory Affairs Specialist?** The compensation package includes health insurance, dental insurance, vision insurance, short term disability, life insurance and Teladoc following an introductory period. The Company offers a 401K plan with employer contribution. The Company also offers paid time off and paid holidays. 7. **What are the working hours for the Regulatory Affairs Specialist position?** The general hours are Monday – Friday, 8:00am to 5:00pm with an hour break for lunch.