22 Sep

Regulatory Affairs Manager Ledige Stillinger på Thermo Fisher Scientific Roskilde

Stilling
Regulatory Affairs Manager
Selskab
Thermo Fisher Scientific
Beliggenhed
Roskilde D85
Er åbningsdato
22 Sep, 2018 30+ days ago

Thermo Fisher Scientific Roskilde presserende behov efter position for Regulatory Affairs Manager. Læs denne jobannonce grundigt før ansøger om jobbet. Der er nogle kvalifikationer, erfaringer og kvalifikationsbehov, at arbejdsgiverne kræver. Er din karriere historie passer disse krav? Sørg for at du forstår den rolle, du søger, og at det er egnet til dine evner og kvalifikationer.

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Regulatory Affairs Manager Ledige Stillinger på Thermo Fisher Scientific Roskilde Detaljer Job:

Job Description

Do you thrive in a dynamic, international leading company, and are you motivated by improving ways of directing and developing Regulatory Affairs? Are you committed and self-driven, and would you like an influential role where you will be enhancing performance whilst applying your Regulatory expertise within Medical Devices, then you may be the one we are looking for.


Our customers are world leading pharma and diagnostics companies who have chosen us as their business partner, and we take great pride in being there for our customers, ensuring total customer satisfaction. At the Roskilde site we produce a variety of consumables (Nunc products) for the medical and biotech industry.

We are now looking for a Regulatory Affairs Manager with real integrity and can-do-attitude to assume responsibility for the development as well as setting the direction within the Regulatory Affairs.


Objectives


As Regulatory Affairs Manager you will be key in the development of the Regulatory strategy for Roskilde and Europe, and at the same time provide RA guidance and support to ensure continued accuracy and compliance with international standards, internal procedures, applicable regulatory and legislation. In this newly created role you will assume responsibility for post-market Surveillance process, as well as you will ensure maintenance and updates of medical device regulatory filing (MDR, IVDR) including product registrations, FDA 510k`s, and Technical Files.


To be successful in this role you will have to show a strong understanding of Regulatory Affairs, and have experience within the Medical Devices sector, preferably with a focus across new regulations in the EU.


Key responsibilities

  • Prepare, submit and manage regulatory filings required for product market approvals and registrations in different markets as necessary
  • Prepare, submit, manage and maintain Technical Files in compliance with the requirements of the MDD/IVDD and the Quality Management System
  • Function as a RA subject matter expert on new product introduction and engineering design control teams
  • Assist the organization, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements and as appropriate
  • Lead post market surveillance activity including assembling necessary evidence and prepare Summary reports as appropriate
  • Lead potential MDR, Vigilance and Recall investigations to conclusion and prepare and file necessary MDR, Vigilance, Recall reports
  • Provide guidance regarding regulatory and compendia performance test requirements such as biocompatibility and sterility

Experience and qualifications needed to succeed
  • Relevant degree in science; Engineering, Pharmacy, Biology, Biochemistry or similar work experience
  • Significant experience working with Regulatory Affairs from Medical Device (IVD, IVF) with working knowledge of device classification processes (domestic and international such as US, Canada, Australia, China, Japan)
  • Working knowledge of ISO 13485 and regulatory requirements for medical devices (including MDD 93/42/EEC, IVDD 98/79/EC, FDA CFR 21 part 820, CMDR)
  • Working knowledge of EN ISO 14971:2012 and experience in utilizing of Risk Management techniques (health hazard evaluation, fault tree analysis, dFMEA, pFMEA etc) for medical devices is required
  • Experienced with post market surveillance activities and familiar with test methods, sampling plans and standard for the design, verification and validation of medical devise products (including sterilization, biocompatibility and packaging validation) is a plus
  • Strong critical thinking skills with attention to detail as well as ability to maintain visibility of the greater picture
  • Good strong communication skills in Danish and English adept with communication at all levels as well as with customers /stakeholders in a professional and effective manner


What we offer

  • A career in an international company with global impact
  • Be part of exciting project to improve human condition
  • Development through continuous learning
  • Cooperation with driven colleagues across business areas
  • Opportunity to work with the best teams in the industry, ranging from international top level scientist to cutting edge process- and production teams and highly creative business- and marketing teams


We will review applications on an ongoing basis in order to start the interview and hiring process as soon as possible, so please do not hesitate in making your application. Deadline for application October 29th 2018.


If you have questions about Thermo Fisher and/or the position please contact Heidi Lund-Nielsen, Senior Recruiter via email Heidi.lund-nielsen@thermofisher.com


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