Regulatory Affairs Specialist Ii
3 weeks ago
**Work mode**:Remote in Country**Onsite Location(s)**:Valencia, CA, US, 91355**Recruiter**: Spencer Gregory Hale**Regulatory Affairs Specialist II - Neuromodulation**
**About the role**:
Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements.**Your responsibilities include**:
- Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies.
- Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals.
- Support product registrations for international markets as required.
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
- Other duties as assigned.
**Required qualifications**:
- A minimum of a bachelor’s degree and 1-3 years’ work experience in regulatory affairs or a masters in regulatory sciences.
- Prior experience with class III Medical Devices
- Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards.
- Effective written and oral communication, technical writing and editing skills
- Works well in fast-paced cross-functional team environments
**Preferred qualifications**:
- Minimum of 7 years experience with Post Market Assessment
- Interpersonal, communication and negotiating skills.
- RA certification (by Regulatory Affairs Professional Society)
**Requisition ID**:580902-
**Nearest Major Market**:Los Angeles
**Job Segment**:Regulatory Affairs, Medical Research, Clinical Research, Compliance, Law, Legal, Healthcare
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