Senior Regulatory Affairs Program Lead – MedTech Surgery

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

📋 Description

• Provide assistance to the Instrumentation & Accessories team within the OTTAVA robotics division

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

• Aid in achieving US and international regulatory approval objectives for new product development

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

• Create submission-ready documentation and draft regulatory submissions

• Facilitate communications with health authorities

• Foster a dynamic regulatory culture across multidisciplinary teams

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

• Develop technical submission documents for global health authorities

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

• Examine specifications, device testing, risk management, and other documents to ensure regulatory compliance and submission readiness

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

• Assess device modifications based on commercial and operational geography requirements and generate necessary submissions, including Letters To File

• Guide adherence to regulations and guidelines regarding product development, claims, labeling, and promotional materials

• Assist in the formulation of Regulatory Affairs processes

⛳️ Requirements

• A minimum of a Bachelor's Degree is required; an advanced degree is highly preferred

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

• Proven experience with regulatory submissions for new medical devices is essential

• Established record of developing and implementing regulatory strategies

• Understanding of the influence of global regulations on product registration

• Strong communication skills for effective collaboration with cross-functional teams

• Ability to engage and collaborate with colleagues globally

• Capacity to assess new regulatory requirements and changes and evaluate their impact on the business

• Excellent verbal and written communication abilities

• High attention to detail

• Advanced analytical and problem-solving capabilities

• Well-organized, capable of managing multiple projects/tasks concurrently and prioritizing efficiently

• Strong aptitude for learning complex technologies

• Presentation skills to articulate complex regulatory strategies clearly, concisely, and thoroughly

• Previous experience in interactions with health authorities

• 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; 48 hours for Colorado residents; 56 hours for Washington residents

• 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

• Inclusive interview accommodations

• Equal opportunity employment