Regulatory Project Manager - Rotkreuz, Schweiz - Work Selection

Work Selection

Geprüftes Unternehmen

Rotkreuz, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Beschreibung:
For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated

Regulatory Project Manager for one year with option for extension.

Tasks:

Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
Monitors and assesses domestic and international Regulatory developments (e.g. Federal Register publication/notices, FDA and EU guidelines, etc.) related to the Company's products
Manages regulatory responsibilities associated with the development, support, and deployment of the Company's nonmedical and medical device software products
Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims
Review promotional materials. May serve as a contact with affiliates to achieve international registration of products
Provide Expertise in Software as a Medical Device (SaMD), MDR, and IVDR and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21 st Century Cures Act and related FDA guidance documents, Medical Device Regulation (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.

Must Haves:

Minimum degree bachelor or masters in engineering or biomedical engineering
At least 5 years of experience in regulatory affairs working within medical device
Experience with MDR
Strong understanding of US regulations and FDA
Profound knowledge of EU guidance documents
Experience with software, SaMD; working knowledge of software and software development
Engagement and communication with global health authorities
Handson experience in stakeholder management
Experience with submissions for US and EU