Senior Regulatory Affairs Program Lead – MedTech Surgery

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the development and implementation of regulatory strategies for the OTTAVA robotic systems portfolio.

• Develop and execute regulatory plans for new product development (NPD) and lifecycle management (LCM) projects.

• Function as the strategic regulatory leader throughout product development, submission, approval, and LCM processes.

• Serve as the regulatory subject matter expert for electromechanical devices that incorporate software-enabled functionality.

• Review specifications, device testing, risk management, labeling, and related documentation, providing regulatory feedback.

• Prepare, compose, and submit FDA filings, including Q-submissions, IDEs, De Novo submissions, and 510(k)s.

• Lead the preparation for FDA meetings.

• Implement sustaining activities such as change assessments, Letters to File, registrations, and renewals.

• Assist in the preparation of technical documents for submissions to global health authorities.

• Utilize expert knowledge of applicable guidelines, regulations, and standards.

• Support audit processes.

• Collaborate closely with engineering and clinical teams to facilitate product development and the creation of submission-ready documentation.

• Aid in communications with health authorities.

⛳️ Requirements

• A minimum of a Bachelor’s degree is required.

• At least 6 years of regulatory affairs experience in medical devices, including expertise with software-enabled systems.

• Demonstrated success in obtaining regulatory approvals, such as 510(k)s, IDEs, and De Novos.

• Highly collaborative and adaptable; able to navigate through ambiguity.

• Strong cross-functional communication skills and the ability to influence regulatory matters and other functions.

• Independent strategic thinker with the ability to integrate guidelines, regulations, and trends into a cohesive regulatory strategy.

• Advanced problem-solving capabilities.

• Experience in assessing new regulatory requirements and changes for their impact on projects.

• Proven experience in managing multiple complex projects.

• Experience in supporting the US market.

• May require travel up to 10% of the time.

• Preferred: previous experience in health authority meeting preparation and participation.

• Preferred: experience with vision systems, robotics, and connected medical platforms.

• Preferred: familiarity with IEC 60601 series and ISO 10993-1 standards.

• Preferred: in-depth knowledge of FDA software and cybersecurity regulatory requirements.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for employees based in Colorado; 56 hours for employees based in Washington.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.