Regulatory Affairs Project Manager

Job content

We are 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 our client quickly. Please note that someone with only pharma experience will not be a fit, we really need MDR experience.Tasks & 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. 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 master 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

If you are interested, or you may know anyone that may be interested, please apply here or you can contact me at mpoenaru@actalentservices.com.Job Title: Regulatory Affairs Project ManagerLocation: Zug, SwitzerlandRate/Salary: 80.00 - 95.00 CHF HourlyJob Type: ContractAerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield