15 publicaciones de empleo destacadas de affairs 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
6h
Administration Specialist [Geely Auto Brand]
Geely Europe —Madrid, Madrid provincia
- Español
- Inglés
- Grado
6d
Communications Specialist for MDS (Mondelez Digital Services)
Mondelēz International —Madrid, Madrid provincia
- Jornada completa
- Microsoft Powerpoint
- Inglés
- Microsoft Office
Specialist Nuclear Development Economics & Finance (f/m/d)
Axpo Group —Madrid, Madrid provincia
- Trabajo híbrido
- Inglés
- Máster
Product Manager Xeljanz, Velsipity, Enbrel and I&I pipeline (Maternity leave 9M)
Pfizer —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Máster
- Grado
7d
Marketing Specialist International
Silicon HR —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Español
- Máster
- Grado
Solicitud rápida
Regional Access Manager, Responsable Regional - Madrid
Theramex —Madrid, Madrid provincia
- Español
- Hospital
- Máster
- Plan de pensiones
9d
Specialist Nuclear Development Economics & Finance (f/m/d)
Axpo —Madrid, Madrid provincia
- Inglés
- Máster
ECC & Logistics Local Professional (f/m/d)
Siemens Healthineers —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Grado
- Administración y dirección de empresas
Group Corporate Governance Counsel / Specialist
ESML SD Iberia Holding S A U —Pozuelo de Alarcón, Madrid provincia
- Jornada completa
- Inglés
- Grado
- Administración y dirección de empresas
Solicitud rápida
Legal & Integrity Specialist - Projects
ABB —Madrid, Madrid provincia
- Jornada completa
- Microsoft Powerpoint
- Microsoft Word
- Español
- Teletrabajo opcional
1d
Specialist Business Consultant Strategy – Pharma Industry
SDG Group —Madrid, Madrid provincia
- Trabajo híbrido
- Inglés
- Grado
- Administración y dirección de empresas
- Oportunidades de crecimiento y desarrollo profesional
Solicitud rápida
Accounts Receivable Collector
Natus Sensory —Pozuelo de Alarcón, Madrid provincia
- Jornada completa
- Español
- Microsoft Excel
- Servicio al cliente
Medical Information Specialist - (Spanish & English Speaking) US hours
EVERSANA —Madrid, Madrid provincia
- Jornada completa
- Teletrabajo
- Microsoft Word
- Español
- Microsoft Excel
Solicitud rápida

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Associate Specialist, Regulatory Affairs HUB ES
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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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