Regulatory Affairs Specialist

Descripción y detalle de las actividades- Determines the regulatory impact of proposed product changes on EU and FDA registrations.- Work independently or with mínimal supervision to review complex- Change Engineering Requests, Document Change Requests, Variances, and other- Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.- Demonstrate expertise and knowledge in EU MDR regulations to fulfill general safety and performance requirements, compile technical files, assist teams in compliance with labeling and distributor/importer requirements and manage the completion of conformity assessments.- Respond to internal/external customer inquiries regarding product regulatory or product issues.- Serve as the RA lead and work in partnership with Product- Development, Manufacturing and QA/QC to ensure overall compliance with US,- Canadian, European, and international regulations.- Lead Unique Device- Identification system requirements and other labeling compliance of new- products introduced into the market. Plan and coordinate rollouts of product- changes with corporate and international regulatory teams.- Serve as RA lead and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR and Field Actions. Develop/review product risk management plans and Failure Mode & Effect Analysis in accordance with FDA/ISO 14971.- Contribute to the authoring of SOPs and train key personnel as needed.- Coordinate and maintain internal regulatory management records, import/export documentations, certificates/permits for product registration/notification to support regulatory compliance or customs clearance.- Creates/updates technical documentation to achieve and maintain MDR certification.Experiência y requisitos- 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 mínimal 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 cycleBeneficios- Beneficios de acuerdo a la LFT**Número de vacantes** 1**Área** Ingeniería**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Tiempo completo- Lunes a viernes**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** No