US Regulatory Affairs Specialist
Altatec(1 month ago)
About this role
This role focuses on obtaining and maintaining medical device product registrations across domestic and international markets. It supports the business by interpreting U.S. and global regulatory requirements and ensuring products can be legally marketed and distributed. The position operates within a regulated environment with interaction across internal teams and external partners to support global market access.
Required Skills
- Regulatory Compliance
- Product Registration
- Global Submissions
- FDA Submissions
- Regulatory Strategy
- Policy Development
- SOP Development
- Risk-Benefit Analysis
- Technical Documentation
- Submission Preparation
+8 more
Qualifications
- Bachelor's Degree
About Altatec
altatec.chAltatec Microtechnologies AG is an innovative small and medium-sized enterprise (SME) located in the heart of Switzerland, specializing in the development and production of products in the field of microtechnology. The company focuses on creating high-quality microelectronics solutions tailored to meet the needs of its clients. With a commitment to innovation, Altatec positions itself as a key player in the microtechnology sector, offering advanced solutions that leverage cutting-edge technology.
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