Senior Regulatory Affairs Program Lead – MedTech Surgery

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.

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

• Facilitate the approval objectives for new product development in both US and international regulatory frameworks.

• Collaborate with engineering and clinical teams throughout the product development lifecycle.

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

• Aid in communications with health authorities.

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

• Develop technical submission documents for global health authorities.

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

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

• Identify potential issues, communicate project timelines, and address factors affecting registration status.

• Assess device modifications and produce necessary regulatory submissions, such as Letters To File.

• Guide adherence to regulations and guidelines in product development, including claims, labeling, and promotional materials.

• Assist in the formulation of Regulatory Affairs processes.

• Collaborate across various functions and internationally to meet regulatory milestones.

⛳️ Requirements

• A minimum of a Bachelor's Degree is required; an Advanced Degree is strongly preferred, with desired fields of study including Science, Engineering, or a related discipline.

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

• Proven experience with regulatory submissions for new medical device products is essential.

• A demonstrated history of creating and executing regulatory strategies is required.

• Solid understanding of how global regulations influence product registration.

• Effective communication skills are necessary for successful collaboration with cross-functional partners.

• Experience in evaluating new regulatory requirements and changes, along with their business implications.

• Exceptional verbal and written communication abilities; strong attention to detail is crucial.

• Advanced analytical and problem-solving capabilities are needed.

• Strong organizational skills with the ability to manage multiple projects/tasks concurrently and prioritize effectively.

• Strong aptitude for learning complex technologies and the ability to present intricate regulatory strategies clearly and comprehensively.

• Previous experience with health authority meetings and interactions is advantageous.

• Familiarity with medical device software guidelines, IEC 60601 standards, sterilization, biocompatibility, and reprocessing requirements, along with related documentation in submissions.

• Willingness and capability to travel up to 25% of the time.

🏝️ Benefits

• Pension plan.

• 401(k) savings plan.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours.

• 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 options available.

• Up to 25% travel required.