Regulatory Affairs Technical Lead

2 weeks ago

Sunnyvale, United States Intuitive Full time

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

This senior individual contributor role in Regulatory Affairs will report to the Director of Regulatory Affairs and perform work for the Multiport da Vinci Surgical System business unit of Intuitive. This role will be focused on creating premarket submissions for the US market for the multiport da Vinci 5 Surgical System. There may be additional postmarket sustaining activities or other cross functional duties as they arise related to da Vinci 5 instruments and accessories or other Intuitive products. A total product life cycle (TPLC) model of work is expected. This role will serve as the RA Technical top person in cross functional teams to bring new products to market. As a Professional 5 level role, the person will serve as a subject matter professional and mentor for RA colleagues and core team members.

Essential Job Duties

Having broad regulatory affairs expertise or unique knowledge, uses skills to contribute to development of company goals and values and to achieve goals in innovative and effective ways. Ability to manage departmental and cross functional projects and teams. Proven track record of leading strategic initiatives from concept through to completion; contributes to budget, resource, and financial planning for projects / programs; coaches and guides other colleagues in advancing their technical and business expertise. Works on significant and unique issues where insights of situations or data requires an evaluation of intangibles. Exercises autonomous judgment in methods, techniques and evaluation criteria for obtaining results. Creates formal networks involving coordination among groups. Consistently communicates effectively across varying organizational levels. Effectively takes the lead in communicating with and influencing senior stakeholders. Acts autonomously to establish methods and procedures on new or special assignments. May supervise activities of others. Self-directed. Can operate and drive results and set priorities with limited supervision. Effectively takes actions and resolves issues that impact multiple teams and departments, given the broad scope of responsibilities often involving complex strategies and high-level goals.

Qualifications

Required Skills and Experience Proven ability to professionally engage with and maintain positive relationships with regulatory agencies (, FDA) with minimal supervision. Experience authoring 510(k) submissions and driving them through to clearance. Must provide a writing sample , , named Correspondent Contact on a cleared 510(k) listed on FDA’s website with a posted 510(k) Summary. Experience authoring Pre-Submissions and holding meetings with FDA. Experience authoring Investigational Device Exemption (IDE) applications. Ability to know about, review, and provide feedback on engineering and other technical or clinical documentation to ensure scientific soundness, technical accuracy, and compliance to applicable rules, regulations, standards, and guidance. Experience creating risk assessment documentation. Ability to interpret regulations and guidance for non-RA professionals. Flexibility and adaptability of thinking, planning, and strategy. Ability to influence stakeholders and to prioritize patient safety while meeting business needs. Ability to find solutions to complex problems. Proactive problem solver. Professional level of knowledge of quality system regulations, risk management, and good documentation practices. Experience using FDA’s eSTAR template and electronic submissions portal.

Required Education and Training

Typically requires a minimum of 12 years of related experience with a STEM Bachelor’s degree; or minimum 8 years of experience and a Master’s degree; or a PhD with minimum 5 years of experience; or equivalent experience.

Working Conditions

Primarily an office environment. May be exposed to tissue, animal, or clinical labs.

Preferred Skills and Experience

Regulatory Affairs Professional Certification for Medical Devices (RAC). Preparing OUS submissions Experience with robotic surgical systems or devices. Working knowledge of human anatomy and physiology. Working knowledge of soft tissue surgical procedures.

Additional Information

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.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

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 / Affirmative Action 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.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

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