Medical Device - Regulatory Affairs Consultant

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. Switzerland
Lausanne
Posting date: 15 Apr 2019
RA.JF.22782_1555327343

ProClinical is partnering with a leading pharmaceutical company to advertise a vacancy for a Medical Device - Regulatory Affairs Consultant position. The Regulatory Affairs Consultant will majorly contribute towards the preparation of any critical regulatory documentation for notifications in the Medical Device area and ensure that the company's products comply with relevant legislation and standards. This job will be based in the company's office in Switzerland.

Job Responsibilities:

  • Preparing submissions of license variations and renewals, setting and communicating timelines for license variations and renewal approvals, and writing clear, accessible product labels and patient information leaflets.
  • Generating records and documentation for inclusion into Technical Files and global regulatory submissions.
  • Working closely with the quality assurance and design teams you will have good knowledge of worldwide regulatory standards and demonstrable experience of ISO13485, CE marking, technical file submissions, and driving regulatory processes and activities.
  • Recommending changes for labelling, manufacturing, and clinical protocol for regulatory compliance.
  • Directing or performing coordinating and preparing document packages for regulatory submissions from all areas of company, internal audits, and inspections.

Skills and Requirements:

  • Experience of working with active devices (IEC 60601, IEC 61010, IEC 62304).
  • Knowledge of compliance with key international standards such as ISO 13485, ISO 14971.
  • Experience in providing technical support and advice within a Medical Devices regulatory environment, preferable experience of liaising with competent authorities.
  • 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 with computer skills, such as MS Office.

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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