Senior Regulatory Affairs Program Lead

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Assist the Instrumentation & Accessories team within the OTTAVA robotics division.

• Aid OTTAVA in achieving regulatory (NPD) approval objectives both in the US and internationally.

• Spearhead the development and execution of regulatory strategies for the portfolio of robotic instruments and accessories.

• Collaborate with engineering and clinical teams throughout the various stages of product development.

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

• Support communications with health authorities.

• Foster a dynamic regulatory culture across cross-functional teams.

• Formulate and implement regulatory strategies for new product clearances and approvals.

• Prepare, draft, and submit FDA submissions, which include Q-submissions, IDEs, De Novo, and 510(k)s, as well as technical submissions for global health authorities.

• Act as a Regulatory Affairs subject matter expert within new product development and engineering design control teams.

• Review specifications, device testing, risk management, and related documentation to ensure regulatory compliance and optimal submission positioning.

• Identify challenges, communicate project timelines, and resolve complex issues that affect registration status.

• Assess device changes and generate necessary regulatory submissions, including Letters To File.

• Guide adherence to regulations and guidance documents throughout product development, claims support, labeling content, and promotional materials.

• Assist in the development of Regulatory Affairs processes.

⛳️ Requirements

• A minimum of a Bachelor's Degree is required; preferred fields of study include Science, Engineering, or a related discipline.

• At least 6+ years of relevant experience in Regulatory Affairs within the Medical Device sector is required (4+ years with an Advanced Degree).

• Experience with new product submissions for medical devices is essential.

• Proven history of developing and implementing regulatory strategies.

• Solid understanding of how global regulations influence product registration.

• Strong communication skills for effective collaboration with cross-functional partners.

• Experience in evaluating new regulatory requirements and changes, along with assessing their impact on business.

• Exceptional verbal and written communication skills; keen attention to detail.

• Strong analytical and problem-solving abilities.

• Highly organized, with the capability to manage multiple projects/tasks simultaneously and prioritize effectively.

• Strong learning aptitude for complex technology and presentation skills to effectively convey intricate regulatory strategies clearly and concisely.

• Previous experience with health authority meetings and interactions.

• Familiarity with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and documentation in submissions.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year.

• 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.

• Up to 25% travel.

• Remote options considered on a case-by-case basis.