Regulatory Relations Specialist jobs in Irvine, CA

Position Requirements

• Minimum two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry
• Minimum one year of active experience applying design controls
• Experience in reviewing and approving technical documentation
• Technical background in engineering, biological, or physical sciences
• Experience effectively managing projects and developing advanced organizational skills
• Ability to multitask and prioritize projects that align with departmental and organizational objectives
• Working knowledge of domestic and international regulations, standards and guidance documents
• Strong writing, verbal and interpersonal communication skills
• Ability to work independently and as part of a team
• Assertive and not afraid to ask questions
• Strategic-minded, analytical and detail-oriented

Preferred

The following skills and attributes are preferred :

• Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices, and International Organization for Standardization (ISO) standards
• Experience with mechanical and electrical medical devices

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical.

Our unique business model empowers team members to have a substantial impact, unlike conventional roles.

Benefits

• Competitive compensation range : $80000 - $100000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.