Regulatory Affairs Coordinator/Specialist (Hybrid)

Founded in the 1980s and rebranded in 2017, we are a privately held chemical and ingredients distribution leader across North America serving markets such as care, food & nutrition, industrial specialties, and life sciences.

We are seeking a Regulatory Affairs Coordinator / Specialist to play a crucial role in ensuring that our products comply with all applicable regulations and standards in the US and CAN. This position involves working closely with cross-functional teams to facilitate the regulatory submission process and maintain compliance throughout the product lifecycle.

Key Responsibilities

• Coordinate and manage regulatory submissions for medical devices and pharmaceuticals.
• Develop and maintain documentation in accordance with FDA regulations and quality assurance standards.
• Assist in the preparation of submissions for clinical trials and other regulatory milestones.
• Collaborate with project management teams to ensure timely delivery of regulatory requirements.
• Monitor changes in regulations to ensure compliance with federal, state, and international laws.
• Support the development and maintenance of Standard Operating Procedures (SOPs) related to regulatory affairs.
• Conduct risk management assessments to identify and mitigate potential compliance issues.
• Communicate effectively with regulatory agencies and internal stakeholders to facilitate approvals and address inquiries.
  
  

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field
• 3 years of experience in regulatory affairs, preferably in the pharmaceutical or medical device industries
• Strong understanding of FDA regulations, FSMA, TSCA, and other relevant safety and compliance standards
• Experience with submission processes for clinical trials and product clearances
• Excellent communication skills, both written and verbal, for effective cross-functional collaboration
• Proficiency in project management and organizational skills to handle multiple priorities efficiently
• Familiarity with electronic submission portals such as CDER Direct and other agency systems
• Knowledge of relevant safety data sheets (SDS) and hazardous materials regulations (DOT, OSHA)
  
  

Benefits

• Comprehensive healthcare, 401(k) matching, and more
• Hybrid work schedules (3 days in office after 90 days)
• Access to learning opportunities and resources to grow in your career
• Be part of a diverse, collaborative, and supportive team
• Work with top brands in a dynamic field and contribute to meaningful growth
  
  

Email Your Resume In Word To

Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:

caroline.veillon@cybercoders.com

• Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : CV5-1845078L410 -- in the email subject line for your application to be considered.***
  
  

Caroline Veillon - Lead Recruiter

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

This job was first posted by CyberCoders on 03/17/2025 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.