Regulatory Affairs Specialist II

About the position

The Regulatory Affairs Specialist II position at Astrix Technology Group involves managing regulatory documentation and submissions for innovative surgical, pharmaceutical, and vision care products. The role is crucial in ensuring compliance with relevant regulations and standards while supporting the R&D team in addressing unmet medical needs. This position is a temp-to-hire opportunity based in Lake Forest, CA, with a focus on both domestic and international regulatory requirements.

Responsibilities

• Manage regulatory documentation databases and coordinate the preparation of regulatory submissions.
• Analyze product complaints and recommend plan of actions reportability actions.
• Develop employee training on regulatory topics and liaise with regulatory agencies regarding compliance and submission strategies.
• Accompany inspectors during audits and provide follow-up information.
• Review and prepare regulatory submissions for domestic and international projects, ensuring compliance with relevant regulations.
• Advise project teams on premarket and labeling requirements, and interpret regulatory changes for corporate policies.
• Conduct technical reviews of data for regulatory submissions and examine promotional materials for compliance.
• Stay informed on regulations and standards, participate in audits, and prepare responses for regulatory agencies.
• Manage recall activities, monitor quality metrics, and oversee laboratory sample preparation.
• Review adverse drug reactions and assess waste management regulations related to hazardous materials and recycling.
• Focus on agricultural regulatory issues, including biotechnology and genetically modified crops.

Requirements

• Bachelor's Degree in the life science field preferred.
• 3-5 years of industry experience.
• Knowledge of U.S., E.U., and Canada MDR.