Senior Regulatory Affairs Specialist

Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department's compliance with regulatory policies and managing both electronic and paper-based documentation. Key responsibilities include leading regulatory submissions (such as CERs for EU MDR), handling responses to regulatory authorities, and working with cross-functional global teams to support all aspects of regulatory affairs.Location: Remote (USA or Canada)Time Zone Requirements: CST or EST onlyCitizenship Requirement: U.S. CitizenshipQualifications:Education/Training/Certifications:Bachelor's or Master's degree with 5+ years in medical device regulatory submissions, ideally in fields like regulatory science, biology, chemistry, clinical research, or paralegal studies.Alternatively, 3+ years of experience with an advanced degree (PhD, PharmD, EdD, DBA, or D.Eng.).Regulatory Affairs Certification (RAC) preferred.Experience Requirements:Essential: Primary author for documents such as CDP, CEP, CER, PMCFP, SSCP, and Technical Documentation for EU MDR Class III, and experience with 510(k) submissions (post-2022, eSTAR experience required).Essential: Experience with EU MDR Class III and 510(k) submissions and regulations (post-2022).Proven international registration experience, specifically with CE MDR.Familiarity with full lifecycle regulatory affairs processes, complaint handling, and regulatory reportability per FDA, MDR, and other regulatory bodies.Project management skills to handle multiple priorities, along with strong organizational skills.Knowledge of regulatory requirements in regions like China (NMPA) and LATAM preferred.Skills and Abilities:Essential: Strong technical and scientific writing skills with experience as a primary author.Ability to interpret and apply country-specific regulatory requirements globally.Thorough knowledge of 510(k) and CE MDR processes and FDA/EU MDR standards for medical device submissions.Strong understanding of labeling requirements (IFUs, labels) under FDA and CE MDR standards.Ability to interpret global regulatory requirements for the organization's medical devices.Excellent verbal communication skills for handling challenging situations and providing leadership solutions.Proficiency with MS Office, Adobe Acrobat, and document management software.Ability to manage multiple tasks, maintain organization, and meet deadlines in a fast-paced environment.Ability to work independently in a remote setting with minimal supervision.

Created: 2024-11-10