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Job Details

Regulatory Affairs Associate

Company: CROMSOURCE
Location: Germany
Reference: HQ00001565
Closing Date: 09 Jan 19
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Description   : Regulatory Affairs Specialist (m/w) : Bayern, Germany   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Specialist (m/w) to strengthen the team of one of our TOP Pharmaceutical client Companies in Bayer, Germany.   Main Job Tasks and Responsibilities   Koordination und Durchführung von Neueinreichungen (global) Strategische regulatorische Planung...

Requirements:

Description

Job Title: Regulatory Affairs Specialist (m/w)

Location: Bayern, Germany

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Specialist (m/w) to strengthen the team of one of our TOP Pharmaceutical client Companies in Bayer, Germany.

Main Job Tasks and Responsibilities

  • Koordination und Durchführung von Neueinreichungen (global)
  • Strategische regulatorische Planung von Zulassungen gemäß Marktanforderungen als Design Input in Zusammenarbeit mit der R&D Abteilung
  • Sicherstellen von Erhalt und Pflege internationaler Zulassungen
  • Terminnachverfolgung bzw. -überwachung
  • Regulatorischer Support von Entwicklungsprojekten
  • Eigenständiges Zusammenstellen von Zulassungsunterlagen z.B. für CE, MEA-Raum oder FDA Einreichungen
  • Einholung von Behördendokumenten, Beglaubigungen, Apostillen etc.
  • Compliance der Zulassungsunterlagen und Daten-/Dokumentenablagesysteme
  • Koordinieren und Review der Risikoanalyse, um ISO 14791 Konformität zu erreichen
  • Review und Freigabe der Qualifizierung von Prozessen, Equipment und Software
  • Verwaltung, Administration und Überwachung der Abteilungs-Intranet Seiten und der zugehörigen RA Datenbanken
  • Normenmanagement

Education and Experience

  • Abgeschlossenes Studium in Medizintechnik, Ingenieurwesen, Naturwissenschaften mit technischer Ausrichtung oder vergleichbare Ausbildung - je technischer desto besser.
  • Mindestens 2-3 Jahre Erfahrung im Bereich Regulatory Affairs und/oder im Qualitätswesen in der Medizintechnik (mind. Klasse II Produkt), Fokus eher auf Regulatory Affairs. Aktive Produkte besser als nicht-aktive. Pharma und IVD schwierig. IVD kommt nur dann möglicherweise in Frage, wenn Software mit enthalten ist. Kombiprodukte aus Pharma und Medical Device OK.
  • Kandidaten aus CRO, CRA, Vigilance kommen nicht in Frage, wenn sie noch keine Zulassungen betreut haben.
  • (technisches) Verständnis komplexer Medizinprodukte
  • Kenntnisse in ISO 13485
  • QSR 21 CFR 820 sehr wünschenswert
  • Deutsch- (ca. ab B2 Level)
  • Fließende Englischkenntnisse in Wort und Schrift
  • sehr gute Organisations- und Kommunikationsfähigkeit in Wort und Schrift
  • Gute Anwenderkenntnisse in MS-Office
  • Erfahrung in Software Validierung oder Validierung (z.B. Produkte, Prozesse) oder Erfahrung in der Zulassung von Software als Medizinprodukt.

If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to alexander.sourounis@cromsource.com

Why TalentSource Life Sciences/Cromsource

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Regulatory Affairs Associate, Regulatory Affairs Officer, Regulatory Affairs Specialist, Regulatory Coordinator

Apply for this job: Regulatory Affairs Associate

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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