CH - QA and Regulatory Consultant - Normal

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
Zug
Posting date: 04 Mar 2019
RA.JF.21805_1551704122

ProClinical is advertising a vacancy for a QA and Regulatory Consultant position with one of the most renowned pharmaceutical companies in the world. This prestigious organisation works across a range of industries from medical devices to pharmaceutical and consumer goods. The position will be with the company's Swiss-based office.

The QA and Regulatory Consultant will provide support in the management, deployment, and implementation of initiatives defined under the implementation of the new regulation for medical devices.

Job Responsibilities:

  • Collaborating with Regulatory OTC in order to collect the data from the dossiers in regard to the medical devices.
  • Collaborating with internal stakeholders and then following up the original communication performed with the EM regarding suppliers of medical devices.
  • Collecting samples of the combination products from Ems and consolidating the overview of artwork information and type of medical device used versus the dossier.
  • Reviewing questionnaires and consolidating an overview.
  • Collaborating with EM Make in order to build the logistic flow for all impacted products under MDR.
  • Connecting with UDI work stream in regard to the combination products list.
  • Supporting additional requests which might come from other WS.
  • Supporting the activity to place QRA between medical device suppliers.
  • Supporting the preparation of the regular updates within the organisation.
  • Collecting documentation from medical devices suppliers.
  • Supporting the QMS workstream.
  • Reviewing potential procedures which would need to be updated due to MDR implementation.

Skills and Requirements:

  • A bachelor's degree in Life Sciences, Pharmacy, or Engineering.
  • A general knowledge of global regulatory requirements, such as ISO 13485, 21 CFR Part 820, etc.
  • Two years of experience in a multinational environment in the MD/Med-Tech industry.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Jay Foster at +44 203 752 0309 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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