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Role: Regulatory Affairs Associate
Location: Alameda, CA 94502
Duration: 12 Months on W2
Shift Timings: 8AM to 5PM


- 100% Onsite in Alameda and hybrid/remote will not be considered so do not submit them.
- Open to National search (Relocation at own expense; maximum time of 3 weeks will be given to the candidate for relocation)

Skills Looking For:
- Senior Regulatory Associate
- Minimum 3 to 4 years Med device for IVDs- Regulatory experience is required.
- Comfortable leading regulatory activities on projects and capable of guiding mentorship and training to more junior members of the team.
- Some Global experience is required in regulatory (US, EU, UK, Latin America).
- Will be working in the Design Control New Product Introductory Substantial change team: working in class (Class IIa/IIb) medical devices, CE marking, and Technical files.
- Design Controls: Working on regulatory activities to support these changes. Regulatory assessments for the change; change notifications and technical body updates to be provided; Approving and Reviewing the documentation for that change- can be risk management file, labeling changes, or design verification reports from a regulatory perspective.
- Day to Day Activities: Working on regulatory impact assessments, reviewing labeling and reviewing design documentation and working on regulatory strategies for new projects that are being proposed, Reviewing Clinical evaluation documentation, and working with global teams in implementing these.

Education and Experience:
- Engineering/Scientific/Medical degree. (Degree is required)
- Minimum 3 to 4 years Med device for IVDs- Regulatory experience is required.

Interview Process:
- Phone screening followed by panel video interview.