Regulatory Affairs Specialist - Normal

Proclinical is advertising a vacancy for a Regulatory Affairs Specialist position with a globally recognised and highly esteemed biopharmaceutical company. The organisation works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries. Based in the company's Swiss office, this position offers an exciting opportunity to work with a top 10 pharma company that employs over 100,000 professionals worldwide.

The Regulatory Affairs Specialist position will support the local franchise Regulatory team with the creation of an IT System documentation and other activities in conjunction with MDR compliance work.

Job Responsibilities:

• Supporting RA Business Lead in development and creation of IT System documentation for new functionality related to Technical Documentation requirements under MDR.
• Performing User Acceptance Testing of newly implemented IT requirements as assigned.
• Providing regulatory support for Life Cycle Management projects as assigned.
• Managing data cleansing and comparison, remediation, and maintenance of existing Technical File documentation as instructed and assigned.
• Performing Regulatory Change assessments as assigned.
• Performing Labeling and Promotional Material Reviews as assigned.

Skills and Requirements:

• Experience in IT system documentation and database management (Product Lifecycle Management (PLM)).
• An understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).
• An understanding of requirements of current Council Directive 93/42/EEC.
• Comprehensive knowledge in the handling with and of data in PLM and ERP system, preferentially experience in Agile e6, ERP (SAP), Windchill.
• Proficiency in English, with German a strong bonus.
• 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 Andrea Rotmistrosvky at +44 203 854 0675 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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