Regulatory Affairs - Medical Device

ProClinical is advertising an exciting opportunity for a Regulatory Affairs - Medical Device position, joining a pharmaceutical company in Switzerland. Our client is a pharmaceutical company that is dedicated to the International Markets, and prides itself on its sensitivity to each country's requirement, and ability to meet that requirement. This is a contracted role.

Job Responsibilities:

• Making a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area, and ensuring that the company's products comply with relevant legislation and standards.
• Preparing submissions of license variations and renewals, setting and communicating timelines for license variations, renewing 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 marketing, technical file submissions, and of driving regulatory processes and activities.
• Recommending changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliances.
• Directing or performing coordinating and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections.

Skills and Requirements:

• Demonstrable experience with active devices such as IEC 60601, IEC 61010, and IEC 62304.
• A thorough knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971.
• Excellent attention to detail.
• Fluency in written and verbal English is essential, with French or German preferred.
• Strong communication, persuasion, presentation, and interpersonal skills.
• Strong team ethos, with a demonstrated track record of success in a fast-moving environment.

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 call Jay Foster on +44 0203 752 0309 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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