Tijuana, Baja California- Beneficios superiores a la LFT
- Remoto
Giro
Manufacturera
Actividad principal
Administración de maquiladoras.
Número de empleados
5000
Sitio Web
Aviso de privacidad
Descripción y detalle de las actividades
- Determines the regulatory impact of proposed product changes on EU and FDA registrations.
- Work independently or with minimal 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.
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in device development and regulatory activities. Reviews labeling and labeling requirements for AG Industries product portfolio.
- 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.
Experiencia 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 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
Beneficios
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