Career Opportunities

Position: Regulatory Affairs Specialist
Organisation: Lifescan Scotland
Location: Inverness

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LifeScan Scotland, part of the Johnson & Johnson family of companies is offering a fantastic opportunity to join their multi-national organisation, while enjoying a great quality of life in the heart of the Highlands. LifeScan is a world leader in the fast growing blood glucose monitoring market, serving diabetes patients across the world.

Senior Regulatory Affairs Specialist
Excellent salary and benefits

Overview:

To assit the Requlatory Affairs Management to meet Global Regulatory Affairs requirements affecting Diabetes Blood Glucose Monitoring Products

To manage department responsibilities for Global pre-market applications and submissions to regulatory agencies. Review and approve labeling, packaging, and promotional materials.

Responsibilities:

• Prepares Global Regulatory Strategies.
• Plans, prepares and co-oridinates the development of premarket applications and related submission to FDA and other regulatory agencies.
• Provides guidance to product development teams regarding conformance with medical devise regulations, data required to substaniate product claims and content of labelling, advertising and promotional materials.
• Develops international product registrations. Provides guidance to product development teams regarding data and information required to prepare sich registrations.
• Development labelling sepcifications and approves propsoed labelling, pacakging, advertising and promitional materials after evaluating confirmance to medical device regulations

Skills/Experience Required:

Essential

• A degree in Science.
• Knowledge and understanding of US FDA Medical/IVDD Device regulations is essential.
• Working knowledge of Microsoft Office – Excel, Word, PowerPoint.
• Experience in regulatory affairs in the medical device, diagnostic, pharmaceutical or related industries.
• Established success in preparing medical device pre-marketing applications.

Desirable

• Knowledge of ISO 9001/13485 requirements.
• Technical experience obtained in an R&amp setting.
• Experience with international health and safety and reimbursement regulations.

Contact:

Marie-Louise Shellard
Email - marie-louises@lfsgb.jnj.com
Tel - 01463 721034
Web - www.jnj.com/careers

Important Documents:

• Applicants Terms of Use
• Recruitment Terms and Conditions
• Recruitment Service Packages