Onsite Premarket Regulatory Strategist

Applied Medical Corporation; Rancho Santa Margarita (CA); Presencial; USD 80.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Education reimbursement

401(k) with employer match

Vacation accrual and holidays

Training and mentorship

Comprehensive benefits

On-campus wellness activities

Descripción de la vacante

Applied Medical Corporation is seeking a Specialist in Premarket Regulatory Affairs to lead regulatory activities in the early stages of product development. This on-site role requires collaboration with cross-functional teams to ensure Quality Systems alignment and regulatory readiness.

The ideal candidate will have at least two years in regulatory affairs or QA for medical devices, with experience in design controls, technical document review, and strong communication skills.

Formación

• Two years of regulatory affairs or quality assurance experience in medical devices.
• At least one year applying design controls.
• Experience reviewing and approving technical documentation.
• Technical background in engineering, biology, or physical sciences.
• Strong project management and organizational skills.
• Ability to multitask and prioritize to meet milestones.
• Knowledge of domestic and international regulations, standards, and guidance.
• Strong writing, verbal, and interpersonal communication skills.

Responsabilidades

• Premarket submission management, including 510K and EU MDR filings.
• Regulatory strategy development to support product development and changes.
• Regulatory compliance monitoring and risk assessment.
• Cross-functional collaboration with engineering, quality, and clinical development teams.

Conocimientos

Regulatory Affairs

Quality Assurance

Design Controls

Technical Writing

Project Management

Regulatory Knowledge

Communication Skills

Team Collaboration

Educación

Engineering/Science background

Descripción del empleo

Applied Medical Corporation is seeking a Specialist in Premarket Regulatory Affairs to lead regulatory activities in the early stages of product development. This on-site role requires collaboration with cross-functional teams to ensure Quality Systems alignment and regulatory readiness.

The ideal candidate will have at least two years in regulatory affairs or QA for medical devices, with experience in design controls, technical document review, and strong communication skills.