Regulatory Affairs Senior Associate

Description The Regulatory Affairs Sr. Associate is an experienced medical device regulatory professional who can independently support and, where appropriate, lead regulatory activities across the product lifecycle. This role is intended for a stronger candidate with hands‑on experience supporting U.S., EU, UK, Canadian, Australian, and other international regulatory requirements. The position provides regulatory strategy input, prepares and maintains submission and technical documentation content, evaluates product and labeling changes, supports post‑market and vigilance obligations, and partners cross‑functionally to ensure compliant, timely execution of business objectives. Regulatory Submissions and Registrations Prepare, compile, review, and support submission packages such as FDA 510(k) files, EU/UK Technical Documentation, CE/UKCA submissions, Canadian and Australian registration support, and international registration packages. Independently maintain regulatory files, registration records, certificates, licenses, declarations, agency correspondence, and objective evidence of compliance. Coordinate with external consultants, Authorized Representatives, importers, distributors, Notified Bodies, and regulatory agencies as needed. Regulatory Strategy and Change Assessment Provide practical regulatory strategy input for new products, product modifications, labeling changes, software/app updates, manufacturing changes, supplier changes, and market expansion activities. Perform and document regulatory impact assessments and change control determinations, including whether submissions, notifications, Technical Documentation updates, or labeling updates are required. Monitor applicable regulations, standards, guidance documents, and agency expectations; communicate impact and recommended actions to management. Technical Documentation and Product Lifecycle Support Maintain and improve Technical Documentation/Design Dossiers, GSPR/Essential Requirements evidence, labeling, IFUs, risk management linkages, clinical evaluation inputs, PMS/PMCF linkages, and Device Master Record regulatory content. Partner with Quality, Clinical/Medical Affairs, Engineering, Manufacturing, Marketing, and Commercial teams to ensure regulatory requirements are incorporated into procedures, records, product claims, and change controls. Support product classification, intended use/indications, claims review, standards gap assessments, and country‑specific registration requirements. Post‑Market, Vigilance and Compliance Support Support complaint, adverse event, vigilance, MDR, FSCA/recall, PMS, PSUR, trend reporting, and Canadian Summary Report activities as applicable to assigned products and markets. Provide regulatory input for CAPAs, nonconformances, deviations, supplier issues, field actions, and audit observations where regulatory impact must be assessed. Support FDA, Notified Body, MDSAP, Health Canada, TGA, and internal audits by preparing documentation, responding to requests, and supporting written responses. Project Leadership and Communication Lead assigned regulatory projects from planning through completion, including timelines, deliverables, follow‑up actions, and cross‑functional accountability. Develop clear written regulatory rationales, decision memos, submission summaries, and management updates. Mentor cross‑functional partners on regulatory processes, documentation expectations, and change control requirements, as appropriate. Other duties may be assigned by manager. Requirements Education Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, Quality, or a related technical field required; advanced degree preferred. RAC certification, ISO 13485 lead auditor training, MDR/MDSAP training, or comparable regulatory credential strongly preferred. Experience 6-10+ years of progressive medical device regulatory affairs experience preferred; strong candidates with directly relevant Class II/global regulatory experience may be considered. Demonstrated hands‑on experience with FDA requirements, 21 CFR Part 820/QMSR transition awareness, ISO 13485:2016, EU MDR 2017/745, UK MDR/UKCA, MDSAP jurisdictions, Health Canada, and TGA expectations. Experience with Class I and Class II medical devices; experience with software, SaMD, connected devices, or prescription/OTC device labeling is a plus. Proven ability to support or lead regulatory submissions, Technical Documentation maintenance, regulatory change assessments, labeling reviews, PMS/vigilance inputs, and audit support. Experience working in an eQMS/document management system and in cross‑functional product development or change control environments. Skills and Competencies Strong regulatory judgment with the ability to interpret requirements, write defensible rationales, and elevate risks appropriately. Excellent technical writing, proofreading, organization, and recordkeeping skills with high attention to detail. Ability to manage multiple priorities, work independently, meet deadlines, and drive closure of open actions. Professional communication style with the ability to influence cross‑functional partners and explain regulatory requirements in practical business terms. Proficiency with Microsoft Office, Adobe/PDF tools, regulatory databases, and document/eQMS systems. Comfortable supporting audits, inspections, agency questions, Notified Body requests, and management reviews. Travel Travel of approximately 20%, including potential support of audits, inspections, supplier visits, regulatory meetings, or trade/business activities. Ability to work in an office and manufacturing/quality system environment and review electronic and paper records for extended periods. #J-18808-Ljbffr ElectroCore Inc