Regulatory Project Manager Contractor

vor 3 Wochen


Rotkreuz, Schweiz Manpower Suisse Vollzeit

**General Information**:

- Start date: asap
- latest Start Date: 1 September 2023
- End date: 1 year
- Extension: yes
- Workplace: ROTKREUZ
- Workload: 100%
- Remote/Home Office: Minimum 1 day a week on-site
- Travel: 5% possibly international travel (maximum 1 a year)
- Fixed working hours y/n: yes

**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.
- 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**:

- Swiss and/or EU nationality or a valid and already existing work permit for Switzerland
- 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 and experience with 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

**Job Type**: 100%

Schedule:

- Monday to Friday

Application Question(s):

- Do you possess Swiss or European citizenship or do you already have a valid work permit for Switzerland?
- When are you available to start to work (required date: ASAP/1st September)?
- How many years of experience in regulatory affairs working within the medical device industry do you have?
- Have you worked with software, especially Software as a Medical Device (SaMD), and do you possess a working knowledge of software and software development
- Do you have experience with US regulations and FDA guidelines related to medical devices?
- Do you have experience with submissions for both the US and EU markets?
- Have you worked with the Medical Device Regulation (MDR)?

Expected Start Date: 01/09/2023



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