Regulatory Affairs Specialist

Regulatory Affairs SpecialistAs a Regulatory Affairs Specialist, you will play a critical role in supporting regulatory compliance and quality systems for medical devices. You will assist in preparing, compiling, formatting, and submitting regulatory filings and maintain regulatory records and product registrations.ResponsibilitiesAssist with the preparation, compilation, formatting, and submission of regulatory filings.Maintain regulatory records, product registrations, declarations of conformity, and submission documentation.Support regulatory agency correspondence and requests for additional information.Participate in U.S. and international product registration and approval activities.Support post-market regulatory requirements, including annual reports and regulatory updates.Assess regulatory impact of product changes, manufacturing transfers, and process modifications.Prepare regulatory documentation, certifications, authorization letters, technical dossiers, and customer compliance requests.Collaborate with Quality Assurance to maintain compliance with applicable regulations and standards.Support internal and external audit preparation activities.Ensure document control and regulatory records are maintained accurately.Assist with the development and maintenance of regulatory procedures and processes.Monitor regulatory changes and communicate potential business impacts.Partner with Engineering, Clinical, Manufacturing, and Quality teams to gather technical information for submissions.Track regulatory deliverables and project timelines.Support regulatory training and compliance awareness initiatives.Contribute to continuous improvement projects within the Regulatory Affairs function.Maintain regulatory databases and information management systems.Essential SkillsExperience in regulatory affairs within the medical device industry.Hands-on experience supporting 510(k) submissions.Knowledge of FDA 21 CFR 820, ISO standards, and EU MDR 2017/745.Proficiency in regulatory submission processes.Strong written and verbal communication skills.Excellent organizational and project management abilities.Ability to work effectively with cross-functional teams.Proficient with Microsoft Office and standard business systems.Additional Skills & QualificationsBachelor's degree in Regulatory Affairs, Biomedical Sciences, Engineering, Life Sciences, or a related field.3–5 years of Regulatory Affairs experience within the medical device industry.Experience working in an FDA-regulated environment.Familiarity with quality systems and regulatory frameworks.Work EnvironmentThe work environment involves collaborating with cross-functional teams, including Engineering, Clinical, Manufacturing, and Quality. You will work with one other team member and report to the regulatory manager. This position requires proficiency in Microsoft Office and other standard business systems.Job Type & LocationThis is a Permanent position based out of Baldwin, NY.Pay and BenefitsThe pay range for this position is $75000.00 - $90000.00/yr.Currently in Baldwin and moving to Woodbury later this year.Workplace TypeThis is a fully onsite position in Baldwin, NY.Application DeadlineThis position is anticipated to close on Aug 17, 2026.