Regulatory Affairs Specialist
Ivemsa
BS/MS in Science with demonstrated in-depth understanding of those principles in a related field. 3-5 years experience in the regulatory field or regulated industry with FDA and applicable international regulations and standards, 4-7 years preferred. Regulatory Affairs Certification (RAC) desired Internal auditor certification Experience working on products that were developed and submitted for 510K. Experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). Must have proven ability to prepare and submit documents to regulatory agencies independently or with minimal supervision. Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Willingness to take ownership and accept responsibility for actions and decisions. Regulatory submission experience with the EU MDR or MDD is required. Experience with MDD-MDR transition and PMS activities. Experience with assigning UDI ( Unique Device Identification) to products Audit experience preferable. (ISO, EU MDR, MDSAP) Demonstrates excellent written, oral, and interpersonal skills with personnel at all levels. Exhibits a high degree of integrity, initiative and motivation. Strong ethics and regulatory compliance awareness Attention to detail and ability to manage multiple tasks Capacity to work independently, with excellent time management and judgment in task prioritization Able to interact with multiple individuals in a positive, constructive manner and under a variety of circumstances. Ability to quickly and effectively build relationships, interact, and communicate information with internal and external stakeholders. Excellent English verbal and written communication skills Computer skills with proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat Familiarity with ISO 14971 Risk Management. Understanding of design controls, DHF, and Gate Process life cycle
Junio 04 2025 en Tijuana
