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Quality

Regulatory Affairs Specialist

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:

Serve as the primary regulatory representative on project and product core teams. The specialist works across the organization in participating in design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products.

Roles & Responsibilities:

  • Develop regulatory pathway for US FDA and Canada new product registration. Provide regulatory input and oversight to product development and manufacturing teams, including review of documentation and communicating applicable regulatory requirements.
  • Assess the impact of the product and process changes, establish regulatory pathways for US and Canada markets, and prepare the corresponding regulatory submission or internal documentation.
  • Gather information from international counterparts regarding submission pathways and impact of changes, and coordinate with international counterparts in global regulatory submissions/approvals.
  • Create and maintain product summary technical file (STED)
  • Identify and convey requirements from applicable standards and guidance documents to project teams.
  • Provide leadership on documentation issues and mentor teams on requirements.
  • Continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.
  • Work directly with regulatory agencies on regulatory issues and submissions.
  • Assist with international regulatory activities upon request.
  • Perform other duties as required

Qualifications

Skills, Experience, Education, & Training:

  • Education: Minimum B.S. or higher in Engineering or in a Science field or equivalent related experience

Experience:

  • Minimum 5 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science)
  • experience with software-controlled and/or standalone software medical devices including cybersecurity is a plus.

Skills:

  • Ability to work in a fast-paced environment and handle multiple projects simultaneously.
  • Ability to create and submit FDA and Canada submissions.
  • Knowledge of design controls with experience in verification and validation methods and documentation and their relevancy to regulatory change assessments
  • Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.
  • Excellent verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
  • Ability to digest and convey information to project teams from regulators including regulations, guidance documents, and standards.
  • Ability to review and provide critical feedback on design documentation.
  • Ability to learn internal procedures and processes and implement on project teams.
  • Good relational skills and ability to work well with cross-functional teams.
  • Good project management skills.

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.

EEO and AA Policy

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: $108,200 USD - $155,800 USD
Base Salary Range Region 2: $92,000 USD - $132,400 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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The Future is Intuitive

At Intuitive, we envision a future where care is more connected, customized, and intelligent—so the question won’t just be how long we live, but how well.

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Our culture is driven by passionate people who truly want to make a difference. Learn more about our unique environment and the characteristics of people who thrive at our company.

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We believe in supporting happy and healthy teams. As a valued team member, your benefits extend far beyond your hourly pay or salary. Learn more about our benefits and perks.

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