Operations Lead

Operations Lead

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

The Operations Lead serves as a centralized project management and operational integration function within the Regulatory Affairs department at Applied Medical. This role enables consistent and compliant execution of regulatory initiatives through structured planning, cross-functional coordination, process standardization, and controlled documentation practices. Acting as a key integration point across local and global functional business, engineering, and regulatory stakeholders, this individual is responsible for managing projects from intake through completion—ensuring well-defined scope, alignment with regulatory requirements, effective stakeholder engagement, and timely delivery across teams. This individual contributor role is ideally suited for professionals with experience in regulatory operations, process improvement, and cross-functional project management within a regulated industry. The role focuses on building scalable operational frameworks to improve execution consistency and timing, thereby supporting the Regulatory Affairs team in completing regulatory deliverables in alignment with organizational initiatives and applicable global requirements (e.g., FDA, EU MDR, ISO 13485).

Key Responsibilities

• Lead the design, documentation, and maintenance of clear and practical processes, procedures, and workflows suitable for a regulated environment.
• Engage with cross-functional teams to assess current state operations, identify process gaps and inefficiencies, and develop structured, scalable solutions that improve execution.
• Interface with global regulatory teams to support projects, process improvement initiatives and provide project management to regulatory submission and regulatory intelligence activities.
• Lead cross-functional regulatory and operational initiatives from initiation through completion, including scope definition, timeline development, risk identification, and milestone tracking.
• Coordinate activities across Regulatory Affairs, Clinical Development, Quality, R&D, global teams and other functions to ensure alignment with regulatory submission timelines and business priorities.
• Develop and maintain high-quality process documentation and project artifacts that are controlled, reusable, and aligned with regulatory standards.
• Utilize internal systems including Enterprise Resource Planning (ERP) platforms, SharePoint, and document management tools to organize and manage project and operational information.
• Support the development and standardization of tools/templates that enhance visibility, consistency, and efficiency across projects.
• Partner with Regulatory Affairs SMEs to ensure operational processes effectively support submission readiness and compliance activities.
• Support documentation organization that ensures alignment with document control requirements and promotes audit-readiness and facilitates traceability.
• Identify systems to improve the overall efficiency of processes within Premarket RA, ensuring alignment with applicable standards and regulations (e.g., 21 CFR Part 820/QMSR, ISO 13485, EU MDR).
• Perform additional duties and responsibilities as required by leadership.

Success in This Role Looks Like

• Delivering well-scoped, clearly documented projects and processes that teams across the organization adopt and use consistently.
• Facilitating productive working sessions that move stakeholders from discussion to clear, actionable decisions.
• Building working knowledge of Applied Medical's systems, workflows, and regulatory environment quickly and applying that knowledge to improve operational execution.
• Maintaining organized, controlled process documentation that meets the standards of a regulated medical device environment.
• Operating independently with strong ownership of projects while collaborating effectively across teams with varying priorities and working styles.

Position Requirements

This Position Requires the Following Skills and Attributes

• Ability to interpret procedures and identify areas for process improvement leading to the development and support of documentation to maintain standard work.
• Strong facilitation skills, including leading meetings and guiding discussions toward concrete outcomes.
• Ability to interact with different global and regional teams with varying priorities and styles.
• Working knowledge of regulated environments or the ability to quickly learn regulatory requirements.
• Strong organizational skills and attention to both detail and overall workflow.
• Ability to work independently and as part of a larger project team
• Demonstrated capability to take ownership of projects.
• Clear written and verbal communication skills.

Preferred

The Following Skills and Attributes Are Preferred

• Working knowledge of regulated environments, including medical device, pharmaceutical, or other quality-controlled industries.
• Experience in process improvement, operational standardization, or project management within a regulated industry.
• Familiarity with ERP systems, SharePoint, or document management tools used in regulated environments.

Benefits

• Competitive compensation range: $71,000 - $85,000 / 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.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.