Qosina Corp.
Manager, Regulatory Affairs
2 days ago
Ronkonkoma
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