Regulatory Affairs Specialist

Sobre esta oportunidad

POSITION SUMMARY: The Regulatory Affairs Specialist I is an entry-level member of LifeSync's Global Quality & Regulatory Affairs organization, based in Costa Rica. The primary focus of the role is to execute assigned regulatory activities, including product and establishment registrations, submission preparation, regulatory change assessments, labeling reviews, and post-market regulatory support. Under the direction of the Director, Global Quality & Regulatory Affairs, the position prepares preliminary assessments for review and approval and provides complementary support for selected Quality Management System (QMS) activities.

, FDA, EUDAMED, Health Canada); track deadlines and escalate potential lapses. Compile, organize, and prepare documentation for FDA 510(k) submissions, Letters to File, EU MDR Technical Documentation, and international registrations under the direction of the Director or designated senior regulatory staff. Maintain regulatory files, submission records, and regulatory tracking logs. Perform preliminary regulatory impact assessments for product, labeling, process, supplier, and QMS changes; document findings and recommendations for review and approval by the Director.

Review labeling, instructions for use (IFUs), and Unique Device Identification (UDI) data against applicable regulatory requirements and established procedures; escalate discrepancies for review. Review complaint investigation records for completeness and adequacy to support regulatory assessments; coordinate with Quality to obtain missing information or clarification of investigation findings and root cause. Perform preliminary reportability assessments under FDA Medical Device Reporting requirements, EU MDR vigilance requirements, and Health Canada requirements; promptly escalate potentially reportable events for final determination by the Director or designated reviewer.

Support complaint trending and the preparation and maintenance of post-market surveillance documentation, including Post-Market Surveillance Reports (PMSRs) and Periodic Safety Update Reports (PSURs), under regulatory supervision. Monitor changes to global regulations, standards, and guidance documents; summarize their potential impact for the Director. Support updates to procedures, templates, and records to reflect regulatory changes. Provide support for QMS maintenance, including document control, procedure updates, and record management within the electronic QMS (eQMS).

Track training assignments and completion across all sites; report overdue training and follow up with managers to support compliance. Support CAPA tracking, internal audits, and audit readiness for MDSAP, notified body, FDA, and customer audits, with emphasis on regulatory records and compliance documentation. , Industrial, Biomedical, or Chemical), Biotechnology, Chemistry, or a related scientific or technical discipline. 1-2 years of experience in regulatory affairs within the medical device, pharmaceutical, or another regulated healthcare industry.

Experience must include hands-on participation in regulatory documentation, product registrations, submission preparation, or regulatory change assessments. Relevant regulatory internships or co-op assignments may be considered. Basic working knowledge of medical device regulatory requirements, including FDA 21 CFR Parts 803, 807, and 820 (QMSR), and EU MDR, with the ability to apply relevant procedures and guidance under supervision. Knowledge ISO 13485 and regulated quality management systems. Fluent written and verbal English and Spanish, with the ability to review technical documentation, prepare clear written communications, and collaborate with global teams.

Proficiency with Microsoft Office applications, particularly Word and Excel. Strong attention to detail, organizational skills, and the ability to maintain accurate records and track multiple deadlines. PREFERRED QUALIFICATIONS Regulatory affairs experience specifically within the medical device industry. Exposure to FDA 510(k) submissions, EU MDR Technical Documentation, Letters to File, or international device registration processes. Familiarity with post-market regulatory activities, including complaint reportability, vigilance, PMSRs, or PSURs.

Exposure to document control, training administration, CAPA tracking, or audit support in an ISO 13485 environment. Experience with an eQMS, regulatory tracking tool, or document management system. Additional coursework or training in medical device regulations or regulatory affairs. English-B2+