\\n ITech Consult AG

Regulatory Project Manager (f/m/d) \\xe2\\x80\\x93 SaMD /ISO13485 /submissions/ medical device / FDA and EU guidelines / MDR/ English

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Regulatory Project Manager

Background:
Roche Information Solution (RIS) is looking for a Regulatory Project Manager Contractor to join our regulatory team. The candidate will support various software as medical device and non-medical device software at different stages of the product lifecycle. This role is responsible for activities associated with regulatory approval or launch of regulated (medical device) and non-regulated software including the overall development, implementation and coordination of regulatory strategies and activities. Responsible for assessment of device changes for regulatory implications. The candidate will be a part of multiple international regulatory projects.

The perfect candidate:
The team is looking for a regulatory affairs expert with experience in Medical Devices. This person should have experience working with US regulatory / FDA. We are looking for someone with previous experience that can support quickly. Please note that someone with only pharma experience will not be a fit, we really need MDR experience.
The candidate should have the following skillsets: effectively manage stakeholders, decision making, problem solving, agile mindset, teamwork, collaboration, and regulatory submissions.

Tasks & Responsibilities:

• Manages regulatory responsibilities associated with the development, support, and deployment of the Company\\xe2\\x80\\x99s 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\\xe2\\x80\\x99s 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.

• Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
• 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 software, SaMD; working knowledge of software and software development
• Strong understanding of US regulations and FDA
• Profound knowledge of EU guidance documents
• Experience with MDR
• Experience with submissions for US and EU
• Engagement and communication with global health authorities
• Hands-on experience in stakeholder management
• Proficient in MS Office applications

Reference Nr.: 922772SDA
Role: Regulatory Project Manager
Industrie: Pharma
Workplace: Rotkreuz (Remote/Home Office: Minimum 1 day a week on-site)
Pensum: 100%
Start: ASAP (open to notice period)
Duration: 12++
Deadline: 28.09.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.

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Branche: EDV

Funktion: Technologie/EDV\\n \\n \\n \\n \\n \\n

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