Sr International Regulatory Affairs Specialist
hace 23 horas
Fort Myers
C2N Diagnostics, a St. Louis based biotechnology company focused on commercializing high-quality in vitro diagnostics for neurodegenerative conditions, is looking for a Sr International Regulatory Affairs Specialist to join its growing Regulatory Affairs team. This position focuses on assigned international regulatory activities for C2N’s diagnostic products, associated software, and laboratory testing services. This position requires demonstrated expertise in the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR), including hands-on experience preparing technical documentation, managing international submissions, and working directly with notified bodies and authorized representatives. The Senior International Regulatory Affairs Specialist will help to develop regulatory strategies, manages registrations and regulatory commitments, and provides guidance throughout the product lifecycle. The role collaborates closely with the Research and Development, Clinical Affairs, Quality Assurance, Laboratory Operations, IT and Commercial teams to support international market access and ongoing compliance. This is a remote position that will report to the Director of Regulatory Affairs. C2N is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status, veteran status, marital or parental status, pregnancy, citizenship status, sexual orientation, gender identity and/or expression or any other characteristic protected by law. Key Duties and Responsibilities • Develop and execute EU and international regulatory strategies, including product qualification, classification, conformity assessment pathways, and country-specific submission requirements under EU IVDR, MDR, and other applicable frameworks, • Prepare, review, and maintain technical documentation and international submissions, including performance and clinical evaluations, risk management documentation, verification and validation evidence, labeling, registrations, renewals, and amendments, • Serve as the primary regulatory contact for notified bodies, authorized representatives, and international regulatory partners; coordinate applications, reviews, certification activities, and responses to regulatory questions and findings, • Collaborate with R&D, Clinical Affairs, Quality Assurance, Laboratory Operations, Software Development, and Commercial teams to align product development, evidence generation, intended purpose, and claims with regulatory requirements, • Assess product, software, manufacturing, specimen collection, and labeling changes to determine their impact on certifications, registrations, and required regulatory actions, • Coordinate applicable EU declarations of conformity, UDI and registration activities, and regulatory responsibilities involving authorized representatives, importers, and distributors, • Support post-market surveillance, performance and clinical follow-up, vigilance reporting, field safety corrective actions, and updates to lifecycle documentation, • Support notified body audits and regulatory inspections, including preparation, responses to findings, and completion of follow-up commitments, • Evaluate country-specific requirements for centralized laboratory testing and cross-border specimen collection, and review labeling and promotional materials for consistency with authorized claims, • Monitor regulatory developments, maintain submission and renewal schedules, communicate risks and requirements to stakeholders, and support U.S. regulatory activities as assigned Required Qualifications • Bachelor’s degree in life sciences, biomedical engineering, or a related discipline, • At least five years of medical device or IVD regulatory affairs experience, including substantial responsibility for European and international submissions, • Demonstrated expertise in both EU IVDR and MDR, with practical experience applying requirements to product development, conformity assessment, and lifecycle management, • Direct experience managing relationships and regulatory communications with notified bodies and EU authorized representatives, • Proven ability to prepare technical documentation and manage notified body questions or deficiencies through resolution, • Experience in preparing and maintaining product registrations in multiple international markets, • Strong knowledge of IVD performance evaluation and familiarity with medical device clinical evaluation requirements, • Working knowledge of ISO 13485, ISO 14971, post-market surveillance, vigilance, labeling, and UDI requirements, • Strong technical writing, project management, and cross-functional communication skills, • Ability to independently manage complex regulatory projects, identify risks, and provide practical, well-supported recommendations Preferred Qualifications • Advanced degree in relevant scientific or technical discipline, • Regulatory Affairs Certification (RAC), • Experience with blood-based biomarkers, mass spectrometry assays, diagnostic algorithms, or software-supported diagnostics, • Experience with Health Canada and other major international regulatory authorities, • Experience with FDA filings for and work on FDA-cleared medical devices, • Familiarity with centralized laboratory testing services and CLIA/CAP laboratory operations, • Experience supporting notified body audits, regulatory inspections, and international product launches Travel and Physical Requirements • This position could require up to 15% travel, including overnight travel, to attend internal and external meetings and conferences, • Ability to sit and stand for up to periods of four (4) hours, • Ability to lift up to thirty (30) pounds in an office environment The potential base pay range for this role is $95,000-$115,000 annually. The actual base salary offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education and experience as well as location. Additionally, bonuses and/or other forms of compensation may be offered, along with a range of health and welfare and/or other benefits including paid time off, 401K plan and medical, dental and vision coverage.
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