Onsite Premarket Regulatory Documentation Specialist

Applied Medical Corporation; Rancho Santa Margarita (CA); Presencial; USD 24.000 - 28.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive pay

Comprehensive benefits

Training & mentorship

Wellness on campus

Education reimbursement

401(k) with discretionary match

Generous vacation & holidays

Descripción de la vacante

Applied Medical Corporation in California is seeking a Documentation Coordinator to ensure accuracy and organization of Premarket Regulatory Affairs documentation. This onsite role prepares, edits, and maintains regulatory documents while supporting registration activities and collaborating with cross‑functional teams.

You will manage a centralized repository, ensure formatting consistency, and identify process improvements to boost efficiency.

Formación

• Associate degree or higher.
• Strong organizational, editing and proofreading skills.
• Excellent written and verbal communication.
• Self-motivated and able to work independently.
• Administrative support experience.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Attention to detail and problem solving.

Responsabilidades

• Organizes and maintains a centralized repository for regulatory documentation, ensuring easy access and retrieval for stakeholders.
• Prepares, creates, edits, and maintains documentation supporting Premarket Regulatory Affairs and registration activities.
• Maintains open communication with team members and stakeholders, addressing queries and providing clarification.
• Reviews documentation for accuracy and confirms proper formatting, fonts, and style.
• Identifies opportunities to improve documentation processes and proposes and implements efficiency gains.

Conocimientos

Organizational skills

Editing & proofreading

Communication

Self-management

Independent contributor

MS Office

Educación

Associate's degree

Herramientas

MS Office

Descripción del empleo

Applied Medical Corporation in California is seeking a Documentation Coordinator to ensure accuracy and organization of Premarket Regulatory Affairs documentation. This onsite role prepares, edits, and maintains regulatory documents while supporting registration activities and collaborating with cross‑functional teams.

You will manage a centralized repository, ensure formatting consistency, and identify process improvements to boost efficiency.