Beschreibung
Regulatory Affairs Manager (f/m/d) - MDR / FDA / SaMD / MS-Office / guidelinesProjekt:
For our client Roche based in Rotkreuz we are looking for a Regulatory Affairs Manager (f/m/d)
Background:
This Regulatory Affairs function belongs to the Roche Information Solutions (RIS) business. As Regulatory Affairs we support regulated (medical device) and non-regulated stand-alone software product portfolio. 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.
Ideal candidate:
To replace internal temporary move and planned workload increase, the team is looking for a regulatory affairs with experience in Medical Devices. This person should have experience working with US regulatory / FDA. We are looking with 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.
On a soft skills note, we need problem solvers, able to find new ways of working when no routine processes are in place; someone collaborative and able to guide the project team when necessary.
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.
* 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.
Must Haves:
* 3 to 4 years minimum in relevant experience
* Experience with MDR
* Experience with US regulations and FDA
* Experience with submissions
* Minimum Master level of education
* Excellent oral and written communication skills
* Consistently neat and accurate reporting
* High attention to detail
* Excellent organizational skills
* Proficient in MS Office applications
* Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization
- Experience with software, SaMD; working knowledge of software and software development
Reference No.: 921761SGR
Role: Regulatory Affairs Manager
Industry: Pharma
Location: Rotkreuz
Workload:100%
Start: ASAP
Duration: 12++
Deadline: 27.07.2022
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.