20 publicaciones de empleo destacadas de regulatory specialist en madrid, md (¡Están contratando!)

Regulatory Affairs Specialist
Straumann Group —Madrid, Madrid provincia
- Jornada completa
- Inglés
Associate Specialist, Regulatory Affairs HUB ES
Abacus Medicine Group —Madrid, Madrid provincia
- Trabajo híbrido
- Español
- Doctorado
- Inglés
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Financial Resource Management Specialist (ALM/IRRBB/FTP/Capital/RWA optimization) – Senior Analyst (Private Bank) (f/m/x)
Deutsche Bank —Salamanca-Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Microsoft Excel
- Inglés
- Plan de pensiones
CRA I/ II- FSP
Thermo Fisher Scientific —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Investigación
- Microsoft Office
Quality Systems Specialist
Medtronic —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Project management
- Grado
10d
Trade Compliance Specialist - Import/Export
ADI Global Distribution —Coslada, Madrid provincia
- Turno de 8 horas
- Español
- Sistemas ERP
- Inglés
- Plan de pensiones
Quality Assurance Specialist
Project Delivery Partners —Madrid, Madrid provincia
- Grado
- Habilidades de comunicación
REGULATORY & IMPLEMENTATION ESG SENIOR ANALYST
BNP Paribas —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Inglés
- Microsoft Office
- Liderazgo
Specialist Nuclear Development Economics & Finance (f/m/d)
Axpo Group —Madrid, Madrid provincia
- Trabajo híbrido
- Inglés
- Máster
Knowledge Specialist - Grid Code
UL Solutions —Madrid, Madrid provincia
- Trabajo híbrido
- Microsoft Word
- Inglés
- Bachillerato
Middle Office Specialist – Asset Management Companies 100% (f/m/d)
Julius Baer —Madrid, Madrid provincia
- Jornada completa
- Español
- Inglés
- Contabilidad
7d
Product & Consumer Protection Compliance Specialist - Compliance (Openbank)
SCO Santander Consumer Finance, S.A. —Madrid, Madrid provincia
- Jornada completa
- Microsoft Powerpoint
- Microsoft Word
- Español
HR Operations Specialist
Morningstar —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Español
- Inglés
- Recursos humanos
Associate Clinical Specialist
Align Technology —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Microsoft Office
- Máster
Solicitud rápida
Credit Analyst / Junior Specialist Credit, Tenancy & Insurance (m/f/d)
Deutsche Pfandbriefbank AG —Madrid, Madrid provincia
- Inglés
- Habilidades de análisis
Climate Risk Specialist (1-year temporary contract, hybrid, Madrid, m/f/x/d), Madrid (M, ES)
Swiss Re —Madrid, Madrid provincia
- Trabajo híbrido
- Doctorado
- Inglés
- Investigación
Product Compliance and Homologation Specialist
BYD Europe —Madrid, Madrid provincia
- Español
- Inglés
- Grado
13d
Quality Specialist
Haleon —Madrid, Madrid provincia
- Jornada completa
- Español
- Inglés
- Máster
8d
Residual Value Risk Specialist - SCF HQ
SCH Banco Santander, S.A. —Boadilla del Monte, Madrid provincia
- Jornada completa
- Microsoft Powerpoint
- Español
- Microsoft Excel
- Abono gimnasio
- Seguro de vida
Strategy Specialist
Allfunds Bank —Madrid, Madrid provincia
- Oficina
- Habilidades de análisis
- Grado

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Regulatory Affairs Specialist

Straumann Group -
Madrid, Madrid provincia

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Detalles del empleo

Jornada completa

Cualificaciones

Inglés

Descripción completa del empleo

Position Summary

The Regulatory Affairs Specialist is responsible for identifying and obtaining scientific, engineering, and regulatory information for review, preparation, and maintenance of technical documentation for submission to regulatory authorities in the countries/regions where the company wishes to market medical products. This position works with the regulatory authorities, or with the local subsidiaries or distributors taking action on behalf of the company, to ensure compliant market access. In addition, this person is responsible for review of promotional material and labeling for compliance with regulations, overseeing annual establishment registrations and device listings, and supporting on-going compliance projects. This position reports to the Head of Regulatory Affairs for ClearCorrect Operating, LLC.

Job Responsibilities

This position is responsible for, but not limited to, the following:

Coordinate acceptance and management of requests for regulatory activities (i.e., Orbit requests).
Generate and review regulatory submissions to obtain compliant market access for distribution of ClearCorrect brand medical products in target markets/regions.
Produce subsequent regulatory submissions (renewals, annual reports, change notifications, memos to file, etc.) to maintain market access in the target markets/regions (e.g., maintains Technical Files and associated documentation for European Union).
Work with the regulatory authorities (or the local subsidiary or distributor acting on behalf of the company) to achieve market access.
Provide input to Product Design teams to assure that regulatory requirements, guidance, and standards are incorporated in the development process; this may include the preparation and maintenance of the associated Regulatory Assessment and Regulatory Strategy documents.
Author, review, and/or approve certain Product Design documentation, complying with design control requirements to facilitate their use in achieving and maintaining access to the markets in which the company participates.
Assess product and manufacturing process changes to determine if regulatory action is required.
Support Unique Device Identifier (UDI) requirements in the target markets/regions.
Review promotional material and labeling to ensure applicable regulatory and company requirements are met.
Keep abreast of new or changed regulations, guidance documents, and consensus standards in the target markets/regions and communicate relevant changes to the appropriate company stakeholders.
Obtain and maintain establishment registrations and device listings in the target markets/regions.
Release of products in distribution control system upon receipt of market access and support product launch activities.
Support Freedom of Information Act requests to the FDA as assigned.
Support logistics/supply chain in providing regulatory information for incoming product shipments.
Support worldwide registration, including overseeing notarization and legalization of documents and overseeing the request for FDA Certificates to Foreign Government, etc.
Support specific compliance projects for target markets/regions.
Other duties where Regulatory Affairs is a stakeholder as assigned.

Minimum Qualifications

Technical or scientific degree or equivalent related work experience.
Minimum 2 years of experience in Regulatory Affairs, other work within the medical device industry, or other work in another regulated industry.
Fluent written and spoken English.

Please note when you apply upload your English version CV

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time

Alternative Locations: Spain : Madrid

Travel Percentage: 0 - 10%

Requisition ID: 19851

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Quiero recibir la alerta de empleo más reciente de regulatory specialist en madrid, md

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