• Contract
  • Zurich/Zug
  • Recruiter: Lhackdon Beck

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Senior Regulatory Manager – 4947 LBD 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking a Regulatory Affairs Manager for long term contract role based in Zug, Switzerland.

 

An ideal candidate should have experience working with US regulatory / FDA. They are looking for someone with previous experience that can support quickly. Please note that someone with only pharma experience will not be a fit, MDR experience is a must.

 

 

Main Responsibilities:

 

  • Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products.
  • 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.
  • 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.
  • Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims.
  • May serve as a contact with affiliates to achieve international registration of products.
  • Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
  • Supports global regulatory initiatives and collaborates with quality and regulatory professionals across the Roche organization.
  • Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21st 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.Regulatory support of the portfolio transformation team, especially divestments (focus data collection, implementation).
  • Track progress of assigned projects, including timelines, dossier deliveries. Alert project team and RA GDD management to risks, issues and achievements.
  • Facilitate communication between regulatory associates and cross-functional project team members.
  • Lead or participate in multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives.

 

Qualifications and Experience:

 

  • Relevant working/residency permit or Swiss/EU-Citizenship required;
  • 3 to 4 years minimum in relevant experience
  • Experience with MDR
  • Experience with US regulations and FDA
  • Experience with submissions
  • Experience with software, SaMD; working knowledge of software and software development
  • Minimum Master level of education
  • Excellent oral and written communication skills
  • Consistently neat and accurate reporting
  • Excellent organizational skills