ISIJP00011312 : Regulatory Affairs Specialist 3 not avail for w2 ref

Job Description This is a remote position. Details Job Posting ID: ISIJP00011312 Job Posting Title: Regulatory Affairs Specialist 3 Description: Sr Regulatory Affairs Specialist Max Bill rate - Open for Remote - Prefer Local to Sunnyvale Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care. Job Description Primary Function of Position: The Regulatory Lead serves as the primary regulatory representative and Subject Matter Expert (SME) within the functional group. The Regulatory Affairs Lead liaises with cross functional organizations, as well as global regulatory counterparts, focusing on product lifecycle management including supporting ongoing product changes and continuous improvement projects. Regulatory expert and SME on the product group, including classifications, indications, applicable regulatory standards and guidance docs., emerging regulations and regulators/industry perspective for the product group. Roles & Responsibilities: • Providing regulatory guidance and direction, inclusive of potential risks, to cross-functional business partners and company leadership. Creatively identifies risk-based solutions and strategies for problem solving • Develop and recommend strategies for new product development and changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility. • Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation • Assess the impact of the product/process changes and determine regulatory pathway for US and EU markets • Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications, and internal “Letters to File”, as applicable. • Core team RA functional lead acted as liaison between cross-functional team and international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals, and implementation roll-out • Provide risk-based guidance and strategic input into projects and issues and help facilitate cross functional alignment and resolution • Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams • Perform other duties as required Qualifications Skills, Experience, Education, & Training: • Education: Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degree with equivalent complex medical device experience acceptable • Experience: Minimum 10 years of experience in Medical Device industry with roles showing increasing responsibility and 5+ years of medical device regulatory affairs experience in US and submissions and EU technical documentation with solid knowledge of medical device regulations in regard to end-to-end product lifecycle management • In-depth understanding of US and EU Medical Device regulations • Extensive working knowledge of design controls, risk management, verification and validation, and product labeling requirements/documentation is required • Experience with complex products including mechanical, electrical, and software elements is a plus • Ability to work in a fast-paced environment and handle multiple projects simultaneously • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions • Team player who seeks to help and learn from colleagues seeing the department success as their own • Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism • Proactively seeks to develop and become well-versed within the regulatory landscape. • RAPS Regulatory Affairs Certification (RAC) is a plus Additional information All your information will be kept confidential according to EEO guidelines. Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Job Posting Start Date: 09/08/2025 Job Posting End Date: 09/07/2026 Business Unit: Regulatory Function Site: United States of America Location: Sunnyvale