26 Sr. Regulatory Affairs Specialist Jobs in Irvine, CA
Inari Medical is Hiring a Sr. Regulatory Affairs Specialist Near Irvine, CA
The Sr. Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy and execution for new devices and device modifications.
Responsibilities
- Participate as the regulatory representative supporting cross-functional project teams.
- Draft and execute regulatory strategies for new product development and device
modifications, including identifying regulatory risks, tracking timelines and submission
deliverables, and establishing contingency plans. - Support RA functional area in the review and approval of change orders, including writing
letters to file where applicable. - Obtain market clearance and approvals for class II and III medical devices, including (but
not limited) to 510(k)s, IDEs, pre-submissions and PMAs. - Create and review project deliverables for regulatory submissions.
- Interact with regulatory agency authorities for initial submission and query resolution.
- Review and approve device labeling and promotional materials.
- Support multiple projects simultaneously.
- Mentor other regulatory affairs specialists.
- Support quality system changes, improvements and audits as needed.
- Develop and maintain regulatory procedures.
- Assist in keeping the company informed of current and proposed regulatory requirements.
- Other duties as assigned
- Bachelor's degree required. Bachelor's degree in life sciences, engineering, or related field preferred.
- Minimum of 5 years of experience in preparing US submissions for medical devices with bachelor's degree OR minimum 3 years of experience with advanced degree.
- Detail oriented with well-developed writing and analytical skills.
- Excellent, proven interpersonal, verbal, and written communication skills.
- Experience in Microsoft Office Suite, including Word, PowerPoint, Excel.
- Interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.
- Regulatory Affairs Certification preferred.
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.
Job Summary
Full Time
$85k-108k (estimate)
06/27/2024
07/15/2024
inarimedical.com
IRVINE, CA
200 - 500
2013
Public
WILLIAM HOFFMAN
$200M - $500M
Medical Technology
Related Companies
About Inari Medical
Inari Medical designs and develops medical devices for the interventional treatment of vascular thrombi and emboli.
The following is the career advancement route for Sr. Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Sr. Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr. Regulatory Affairs Specialist. You can explore the career advancement for a Sr. Regulatory Affairs Specialist below and select your interested title to get hiring information.
