Bruker Corporation

Regulatory Affairs Specialist (m/f/d)

Arbeitsort DE-HB-Bremen
Datum der Veröffentlichung 4 months ago(12/20/2019 3:27 AM)
Antrags-Nr.:
2019-8350
Anzahl offener Funktionen
1
Positionstyp
Regular Full-Time

Überblick

As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,000 employees are working on this permanent challenge, at over 70 locations on all continents.

Aufgaben/Verantwortlichkeiten

The Regulatory Affairs Specialist is responsible for providing support to the Global Regulatory Affairs Team in order to ensure compliance with In Vitro Diagnostics regulations within the EU and worldwide. The Regulatory Affairs Specialist will assist in preparation of regulatory submissions, monitor approval progress, and work with RA management to ensure compliance with regulatory agency regulations. He/she will assist in product registrations within the EU and globally.

 

  • As directed by the Global Regulatory Affairs Director, writes, coordinates, compiles, and submits Regulatory documents to regulatory authorities (directly or through partner, as required).
  • Prepares international documents, including Technical Files compliant with IVDD/IVDR and other international regulations and guidelines as required by the global RA Team in Bremen.
  • Works with Management to ensure rapid and timely approval of new products and continued regulatory support of marketed products.
  • As directed, reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments.
  • Provides regulatory advice to project teams as requested by the Global RA Director.
  • When required evaluates proposed product modifications for regulatory impact on a world-wide basis.
  • Completes regulatory assessments.
  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies’ questions and other correspondence (subject to approval by the Global RA Director).
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Develops timelines for submissions under the direction of the Global RA Director.
  • Under coordination from the Global RA Director, engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
  • Monitors international regulations, guidance documents, and competitor news, and assists in the development of best practices for Regulatory Affairs processes within the organization.
  • Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Reviews regulatory authorization related to ongoing product design changes and field action investigations as directed by the Global RA Director.

Qualifikationen

  • Bachelor and/or Master’s Degree in an appropriate subject (preferably Science or Engineering)
  • Some experience in registration of in vitro diagnostics (preferred)
  • Solid knowledge of in vitro diagnostic regulations and review processes within the EU and worldwide.
  • Practical experience in an in vitro diagnostic (IVD) regulatory environment, preparing regulatory submissions.
  • Experience interacting with regulatory authorities is preferred.
  • Excellent written and oral skills in the English and German languages.
  • Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
  • Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
  • Ability to work as a member of a team in a timeline-driven environment with limited supervision.
  • Detail-oriented, while having the ability to handle multiple ongoing projects/tasks.
  • Microsoft Office & Outlook including ability to work with advanced applications in Excel.

Optionen

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