- Beneficios de acuerdo a la LFT
Especialista de Cumplimiento Regulatorio (ISO 13485)
Thermo Fisher Scientific (Planta Tijuana)
Monterrey, Nuevo León
Hace una hora
Compartir:
Corporativo
Giro
Maquiladora (Export.)
Actividad principal
Manufactura, empaque de artículos médicos desechables y moldeo por inyección.
Número de empleados
1000
Sitio Web corporativo
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Descripción y detalle de las actividades
Review and update of EU MDR/IVDR Technical Files and support to the RA mailbox regarding Change Orders, product related questions, complaints and non-conformities, etc. for sites in Tijuana, Monterrey and Roskilde.
- Work for regulatory activities in cooperation with the existing RA team and Sr RA Manager
- Support product development by facilitating globally focused regulatory strategies to drive market access.
- Draft regulatory plans and verification reports to ensure products meet regulatory requirements in all target market regions.
- Responsible for updating the CE technical files for medical products.
- Participate in and ensure follow up on customer requests in the RA mailbox.
- Review and approve product development reports, non-conformance reports, product changes, label content and new product data.
- Provide general quality support to the organization e.g. TrackWise, complaint, observations, CAPA, NC, CO’s, product registration and technical file questions etc.
- Additionally, be part of the risk evaluation in related quality tasks.
- Optimize, document and implement RA processes in QMS regarding regulatory procedures.
- Support external and internal audits. E.g. participate in the Notified Body audit back office to provide documentation and explanation for the technical file documentation.
- Minimum BA/BS degree in a scientific or engineering field (preferred: biology, chemistry, material science, polymer science).
- At least 2 years of experience in a regulated industry (pharmaceutical or medical device).
- Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements
- Analytical mind-set and a great ability to learn new professional fields and business processes
- Great ability to structured and goal-oriented manner
- Excellent communication and team-building skills
Experiencia y requisitos
- A positive approach and motivated by challenges
- Team-player mentality
- Dedicated with the ability to handle tasks independently
- Flexibility to handle shifting priorities
- Confidence in collaborating with colleagues at all levels
- Strong written communication skills, with technical writing experience being a plus
- Excellent critical thinking and decision-making skills
- A continuous improvement approach
- Innovative problem-solving ability
- Strong organizational skills with attention to detail
The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. TThe RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS).
- Ensure availability of up-to-date technical documentation and Standard Operating Procedures
- Work together with LPE global teams for supporting customer requests with related RA mailboxes
- Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods
- Support international registrations with related technical documentation
- Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing
- Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products
- Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints
- Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)
Beneficios
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Número de vacantes 1
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Salario mensual neto $1,000 - $1,650 MXN
Estudios Carrera sin título
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No