Regulatory Affairs Manager

Vor 7 Tagen


Schweiz ELAN Personal AG Vollzeit

LINK KOPIEREN

For our longstanding and well-known client, **Roche Diagnostics International AG**, we are looking for a long-term temporary assignment for the **Rotkreuz** site as a

**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
- Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization

**Nice to Haves**:

- Experience with software, SaMD; working knowledge of software and software development

**Our offer**:

- The chance to get involved in one of the most successful pharmaceutical companies in the world
- Attractive and punctual remuneration
- A partner at your side who focuses on honesty and quality

**Ihr direkter Ansprechpartner**:
Renata Santos

ELAN Personal AG
Frau Renata Santos
Personalberaterin
Luzernerstrasse 69
6030 Ebikon

+41415451010



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