Job Description

#VB_Healthcare_Jobs#24

Job Description: Senior Regulatory Affairs Specialist

• Location: Irvine, CA 92614
• Salary: upto $140,000 per year
• Travel: Up to 10%

Benefits:

• Medical, Dental, and Vision Insurance
• Disability Insurance
• 401(k) Retirement Plan

Job Summary

We are looking for a Senior Regulatory Affairs Specialist to join our team in Irvine, CA. The ideal candidate will have experience working with Class I, II, and III medical devices and a deep understanding of medical device regulations. In this role, you will manage regulatory submissions, ensure compliance with domestic and international standards, and work closely with cross-functional teams to support product approvals.

Key Responsibilities

• Prepare and submit regulatory documents such as 510(k), PMA, IDEs, and technical files.
• Ensure compliance with FDA, ISO 13485, MDR, and other international regulations.
• Work with internal teams to support new product registrations and market approvals.
• Lead regulatory projects and manage timelines to ensure timely submissions.
• Stay updated on regulatory changes and ensure the company meets all requirements.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Engineering, or related field.
• At least 5 years of experience in Regulatory Affairs, with a focus on medical devices.
• Experience with Class I, II, and III medical devices and regulatory submissions.
• Knowledge of FDA, MDR, ISO 13485, and other applicable regulations.

If you meet the qualifications and are excited to contribute to our success, apply today!

Email- Ananyaa@vbeyond.com

Job Types: Full-time, Contract

Pay: $120,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• Knowledge of FDA, MDR, ISO 13485, and other applicable regulations?

Education:

• Master's (Preferred)

Experience:

• Regulatory Affairs, with a focus on medical devices.: 5 years (Required)
• Class I, II, and III medical devices: 2 years (Required)

Work Location: On the road

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