Sr. Regulatory Affairs Specialist

Annual Salary: $100k - 120k plus bonus

Location: Union City, CA

Position Overview

We are seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a crucial role in ensuring that our medical devices comply with all applicable regulatory requirements. This position involves working closely with cross-functional teams to facilitate the approval and registration of products both domestically and internationally.

Key Responsibilities

• Develop and implement regulatory strategies for medical devices to ensure compliance with FDA regulations and international standards.
• Prepare and submit regulatory documents, including 510(k) submissions, IDE applications, and international registrations.
• Review product labeling, promotional materials, and technical documentation to ensure compliance with regulatory standards.
• Act as a liaison with regulatory agencies to address inquiries and resolve issues related to product submissions and approvals.
• Monitor changes in regulations and industry standards to assess their impact on the organization and product development.
• Provide guidance and training to team members on regulatory requirements and best practices.
  
  

Qualifications

• Bachelor's degree in a relevant field (e.g., life sciences, engineering, or related discipline).
• A minimum of 5 years of experience in regulatory affairs 2+ years for medical devices.
• In-depth knowledge of the 21 Code of Federal Regulations, Part 820 Quality System Regulations, and FDA guidelines.
• Experience with international product registration, submission and post market experience.
• Strong analytical and problem-solving skills with attention to detail.
• knowledge of the regulations/requirements for the following: cybersecurity, wireless and sterile products
  
  

Benefits

We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

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Ashley Upchurch - Associate Manager

For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa.

CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.

This job was first posted by CyberCoders on 05/02/2025 and applications will be accepted on an ongoing basis until the position is filled or closed.

CyberCoders is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.