Regulatory Affairs Specialist 3

Regulatory Affairs Specialist 3

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 Regulatory Affairs Specialist 3 works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products.

Essential Job Duties

• Develop regulatory pathway for US FDA and Canada new product registration, support product development and manufacturing teams in providing regulatory input and oversight, including review of documentation and communicating applicable regulatory requirements.
• Assess the impact of the product and process changes, determine regulatory pathways for US and Canada markets, and prepare the corresponding regulatory submission or internal documentation.
• Author regulatory submissions for US FDA 510(k) premarket notifications, internal "Letters to File" and Health Canada registration, and lead the review process through clearance / approval, where applicable.
• Gather information from international counterparts regarding submission pathways and impact of changes and support 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.
• Support international regulatory activities upon request.
• Perform other duties as required

Qualifications

Required Skills and Experience

Required Education and Training

Preferred Skills and Experience

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 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 compensation ranges are listed.