Senior Regulatory Affairs Program Lead – MedTech Surgery

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

📋 Description

• Assist the OTTAVA robotics team in meeting regulatory approval objectives for both the US and international markets.

• Oversee the formulation and execution of regulatory strategies for the portfolio of robotic systems.

• Work in collaboration with engineering and clinical teams throughout the product development lifecycle.

• Create documentation that is ready for submission and draft regulatory submissions.

• Facilitate communications with health authorities.

• Prepare and implement regulatory strategies for New Product Development (NPD) and Lifecycle Management (LCM) initiatives.

• Act as the strategic regulatory lead throughout product development, submission processes, approval, and LCM activities.

• Serve as a regulatory subject-matter expert for electromechanical devices with software-enabled capabilities.

• Review specifications, device testing, risk management, labeling, and associated documentation.

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

• Lead the preparation for FDA meetings.

• Execute ongoing activities, including change assessments, Letters to File, registrations, and renewals.

• Support the creation of technical documents for global health authority submissions.

• Apply relevant regulatory guidance, regulations, and standards to the product portfolio.

• Assist with audits.

⛳️ Requirements

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

• At least 6+ years of experience in regulatory affairs within the medical devices sector, 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; comfortable working through uncertainties.

• Excellent communication skills across functions and the ability to influence within the regulatory team.

• Independent strategic thinker with the capability to synthesize regulatory-relevant information into a business-aligned strategy.

• Strong problem-solving abilities.

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

• Proven experience in managing multiple complex projects.

• Experience supporting the US market is essential.

• May require up to 10% travel.

• Preferred: experience in health authority meeting preparation.

• Preferred: background in vision systems, robotics, and connected medical platforms.

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

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

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

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

• Remote work option.