Regulatory Affairs Associate

Zymo Research Corporation•Tustin, CA

2d•Onsite

About The Position

Zymo Research is seeking a motivated individual to join our Regulatory Affairs team as an entry-level Regulatory Affairs Associate. This role is crucial for supporting regulatory activities and ensuring compliance with applicable requirements. The associate will utilize their skills in regulatory documentation, coordination, and compliance support to maintain high-quality, compliant regulatory processes. This position offers training and guidance from experienced personnel and may support affiliated companies as needed.

Requirements

Bachelor’s degree in a science or related discipline preferred.
Entry-level candidates and recent graduates are encouraged to apply; prior Regulatory Affairs experience is not required.
Demonstrated interest in developing a long-term career in Regulatory Affairs.
Positive, collaborative, and professional attitude with a strong willingness to learn and contribute to the team.
Demonstrates initiative, ownership, and willingness to take on new responsibilities and unfamiliar assignments as learning opportunities.
Flexible and adaptable, with the ability to research and work through regulatory questions that may require interpretation, judgment, and guidance.
Highly organized and efficient, with strong attention to detail, time management, and ability to prioritize multiple tasks.
Ability to work independently when appropriate, use MS Office to organize information for reports and presentations, and handle confidential information with professional integrity.

Responsibilities

Support company registrations and device listings in domestic (U.S.) and international markets
Support preparation and maintenance of IVDD/IVDR technical documentation and registrations
Support product registrations and regulatory submissions to FDA and other regulatory bodies including 510(k) submissions as applicable
Research applicable regulations, standards, and guidance documents and summarize findings for review
Assist with reviewing and writing SOPs and other Regulatory Affairs policies as necessary
Coordinate with cross functional teams regarding product changes and regulatory notification and/or approval requirements
Perform initial reviews of marketing materials, labels, and public communications for regulatory compliance under guidance
Assist with evaluating product compliance with applicable regulations and project requirements
Assist with and participate in notified body audits, ISO registrar audits, government inspections, customer audits, and other audits or regulatory activities as needed
Support Regulatory Affairs projects across Zymo Research and affiliated companies and perform other related duties as business needs require