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Job DescriptionDescription: Position Summary: The Chemist is responsible for and has experience in performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs. Responsibilities: Responsibilities include, but are not limited to: • Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc., • Perform routine laboratory chemical analysis on finished product, stability, raw material, and/or investigation samples, as assigned, using HPLC, UPLC, GC, UV-vis, FTIR, ICP, TOC and other wet chemistry techniques in accordance with the prescribed approved analytical test method., • Maintain a clean and organized laboratory working environment., • Dispose of used/expired/excess chemicals, solutions, solvents, etc. in dedicated waste receptacles., • Report well-written, accurate and timely results., • Review data, calculations, notebooks, and reports., • Assist in laboratory investigations, as assigned., • Assist in Cleaning, Method and Process validation testing and protocol/report review, as assigned., • Assist in maintaining and troubleshooting laboratory equipment., • Suggest improvements to existing testing methods when possible., • Mentor and give guidance to entry-level personnel on techniques performed in the lab and assist with laboratory related questions as needed., • Assist with routine Metrology functions, including instrument cleaning/ preventive maintenance/ calibration/ verification activities., • Monitor and assist with maintaining proper inventory levels of all laboratory supplies., • Assist with sample receiving, chemical inventory, document filing, housekeeping, etc., • Bachelor’s degree in a science related field., • Knowledge of laboratory chemistry and cGMPs., • Proficient in Microsoft Word, Excel, graphs/charts and databases., • Proficient in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, and wet chemistry testing., • Proficient with analytical laboratory software., • Able to multitask and meet tight deadlines., • Excellent organizational skills with attention to detail., • Able to effectively present results., • Able to perform testing on many methods and troubleshoot minor method issues. May require some guidance/supervision as needed., • Required to sit and stand for long periods of time., • Frequently reaching with arms/hands up to 2 feet., • Good hand eye coordination., • Occasionally required to walk and kneel., • Must be able to lift and/or move up to 50 pounds., • Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus., • Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls., • Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders., • Potential to move between production operations sites/areas to complete job functions., • Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion., • Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers. $50,000 - $80,000 per year

Job DescriptionJob Title: Regulatory Affairs Manager Location: Suffolk County, NY (Hybrid/On-site) Reports To: Sr. Director, Client Success & Supply Chain Team Collaboration: Quality Assurance Manager, Quality Control Manager, Supply Chain, Product Development, Marketing, Logistics Company Overview We are a mid-size global distributor of bulk, non-sterile medical device components, FDA-registered and certified to ISO 13485, ISO 9001, ISO 14001, ISO 22301, ISO 45001, and compliant with ISO 26000. As we prepare to expand our business into new areas, we are seeking a Regulatory Affairs Manager to lead our compliance strategy and ensure readiness for new market territories and product lines. Position Summary The Regulatory Affairs Manager will be responsible for overseeing regulatory compliance across all product categories and markets. This role is critical in assessing regulatory risk, ensuring adherence to global standards, and supporting strategic growth initiatives. The ideal candidate will have deep expertise in FDA 510(k), EU MDR, and global medical device regulations, with the ability to identify regulatory classifications even at the component level. Key Responsibilities • Lead regulatory strategy for new product lines and market territories, including direct hospital and clinic sales., • Manage and execute FDA 510(k) submissions, EU MDR registrations, and other global regulatory filings., • Identify and classify medical devices and components per applicable regulations., • Collaborate cross-functionally with QA, QC, Supply Chain, Product Development, Marketing, and Logistics teams., • Ensure regulatory compliance during product onboarding, marketing, and importation., • Conduct and manage internal and external audits; support certification maintenance and renewals., • Develop and maintain regulatory documentation and QMS processes., • Drive validation activities including process, equipment, and software validation., • Support continuous improvement initiatives using Lean Six Sigma methodologies., • Communicate effectively with engineers and technical teams to resolve compliance and quality issues., • Monitor regulatory changes and assess impact on business operations., • Provide training and guidance on regulatory topics across departments., • Lead the company’s sustainability efforts, ensuring regulatory compliance with environmental and social responsibility standards (e.g., ISO 14001, ISO 26000, CSRD, CSDD).Qualifications, • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related field (Master’s preferred)., • 7+ years of experience in regulatory affairs within the medical device industry., • Proven experience with FDA 510(k), EU MDR, and international regulatory frameworks., • Certification in QMS (e.g., ISO 13485 Lead Auditor) or equivalent., • Strong knowledge of ISO standards and validation processes., • Experience with internal/external audits and regulatory inspections., • Lean Six Sigma certification or demonstrated experience in CI projects., • Excellent communication and cross-functional collaboration skills., • Ability to interpret technical documentation and regulatory requirements., • Strategic mindset with hands-on execution capability.Preferred Skills, • RAC (Regulatory Affairs Certification) or similar credential., • Experience in component-level classification and risk assessment., • Familiarity with import/export compliance and logistics coordination., • Knowledge of sustainability and social responsibility