Regulatory Affairs Specialist 3 (Remote)

Pay Rate: $100-$110 per hour100% Remote, prefer EST time zone, must be able to work 8am - 5pm ESTNo Travel required at this time, that could change but it would be minimal1 Year assignment at this time. No plans to extend or convert at this time.Essential Duties and ResponsibilitiesResponsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Participates in technical review of data or reports that will be incorporated.Manage and maintain regulatory databases and technical files.Participate in internal and external audits and investigations.Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.Provides high-level regulatory support on projects and cross functional teams.Provides technical guidance on design reviews and regulatory strategies for product approval.Contribute to developing or improving processes, procedures and standards that contribute to meeting internal SOP’s, regulatory and industry regulations.Maintains current knowledge of existing and emerging regulations, standards and laws.Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), reviewing and responding to emails and other messaging platforms.QualificationsEducationBachelor's Degree (Engineering, Biomedical or related field preferred), May have Master’s Degree, May have PhDExperience5-8 Years, Higher education may compensate for years of experience.Skills RequiredExcellent communication, including verbal, technical writing, interpersonal and presentation skills.Proficient with technology applications such as MS Office,Experience with the creation of technical files and documentationExperience working in regulated medical device industry.Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA and foreign regulatory requirementsStrong data and statistical analysis skills and ability to use data to make informed recommendationsHigh degree of attention to detailBeneficialRegulatory Affairs Certification (RAC)Project Management ExperienceFDA ESTAR experienceAbility to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment