Regulatory Operations Specialist

4 weeks ago

Sunnyvale, United States Intuitive Full time

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.


Responsibilities/Duties:

Understands Intuitive products and has experience working in Regulatory Affairs for a robot-assisted surgical medical device company.

Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide arecurrent, up-to-date.

Creates technical documentation for global submissions taking into consideration international and domestic requirements.

Supports in creation and/or improvement of processes used by regulatory affairs to support the business.

Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.

Assists in assessing standards and regulations which are relevant to medical devices.

Work with cross functional teams including manufacturing, business operations, project management, labeling, quality, global regulatory etc.

Monitor and trend processes to identify issues and improve hand-offs. Proactively identify areas of improvement.

Supports Import/Export needs for Intuitive products.

Audit support for regulatory deliverables, process, and data.

Understand India Regulations and help with submissions specific to India.


Qualifications

Education/Experience: Bachelor’s degree in Pharmaceutical Sciences or a related field of study or the foreign academic equivalent.

Other requirements:

Experience with the following:

regulatory affairs processes related to product release including design development, change control, regulatory assessments and lifecycle management;

regulatory guidance and interpretation on impact of standard and changes in standard;

US FDA commitments such as establishment registration renewals and laser reports, management of device listings.


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.

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