Regulatory Affairs Lead at Intuitive Surgical, Inc. in Sunnyvale, California

Job Description:

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. The Regulatory Lead is an regulatory SME on the product group, including classifications, indications, applicable regulatory standards and guidance documents, emerging regulations, and regulators and industry perspectives for the product group

Roles & Responsibilities:

• Provide regulatory guidance and direction, including potential risks, to cross-functional business partners and company leadership. Creatively identify risk-based solutions and strategies for problem-solving.


• Develop and recommend strategies for new product development and changes to products, including alterations to design, materials, labeling, packaging, manufacturing processes, and facilities.


• Support product engineering and manufacturing teams on regulatory issues, including reviewing design input, risk management, and test documentation.


• Assess the impact of product/process changes and determine regulatory pathways for the U.S. and Canadian markets.


• Lead, plan, coordinate, and prepare U.S. and Canada regulatory submissions of various types, including Pre-sub, FDA 510(k) premarket notifications, internal "Letters to File,", Canada license application, and amendment, etc., as applicable.


• Act as the core team RA functional lead, serving as a liaison between cross-functional teams and international counterparts for the rest of the world (ROW) regarding the impact of changes and working with international counterparts to coordinate global regulatory submissions/approvals and implementation roll-out.


• Provide risk-based guidance and strategic input into projects and issues, facilitating cross-functional alignment and resolution.


• Offer 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 degrees with equivalent complex medical device experience are acceptable.


• 
  Experience: Minimum of 10 years of experience in the Medical Device industry with roles showing increasing responsibility and 5+ years of medical device regulatory affairs experience in the US, including submissions, with solid knowledge of medical device regulations throughout the product lifecycle.


• In-depth understanding of US Medical Device regulations. Fundamental knowledge of EU Medical Device regulation. Experience in Canada is a plus but not required.


• 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 department success as their own.


• Strong interpersonal, negotiation, and 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

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.

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.

Base Salary Range Region 1: $161,500 USD - $232,500 USD
Base Salary Range Region 2: $137,400 USD - $197,700 USD
Shift: Day
Travel: None
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.

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