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  1 year contract opportunity - W2 (No C2C)
• Compensation: $ 50 - $ 55/hr
• 100% Remote

At Intuitive, 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 in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s most complex challenges.

Join us in making big leaps forward for healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.

Roles & Responsibilities:

• Provides regulatory guidance and defines regulatory strategy for digital products by translating complex regulatory concepts into understandable principles.
• Directs or performs coordination and preparation of document packages for complex medical device regulatory submissions based on company objectives and timelines.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Represents Intuitive’s regulatory strategy with US FDA or other competent authorities.
• Supports regulatory strategy, labeling, manufacturing, marketing, and clinical protocol to achieve regulatory clearance.
• Independently advises cross-functional teams and share knowledge and expertise to support development and training of team members.
• Supports clearance of non-medical devices

Additional activities

• Ensures that company procedures, processes and documentation meet requirements of the Quality Management System, ISO 13485 and other applicable regulations.
• Implements and supports Quality Management system activities such as CAPA, management review and internal & external audits as needed.
• Other regulatory tasks and projects may be assigned as necessary.

Skills, Experience, Education, & Training:

• At least 5+ years of significant experience in regulatory affairs and quality compliance for medical devices according to EU regulation
• A Bachelors or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
• In Depth knowledge of US FDA 21 CFR 820.30 and US clearance pathway (510(k)), including US FDA guidances on digital devices
• Knowledge of European Medical Device Regulation (2017/745/EU)
• Significant experience in design control, including new product development
• Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results.
• Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
• Detail oriented, strong ability to identify processes that are not robust.
• Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent (C1 minimum) in written and spoken English
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)

Preferred Knowledge, Skills, and Experience:

• RAC certification
• Prior experience working on Software as a medical device and/or digital technologies
• Knowledge of non-medical device regulations (eg FCC, CE Marking, …)

Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise who manages Intuitive’s Contractor Talent Community. If you are selected for this role, you will be employed by Raise and will not be an employee of Intuitive.

Work with an Award Winning Employer:

• Best Places to Work, Glassdoor Employees’ Choice, 2019 (#12 of 100), 2020 (#7 of 100)
• America’s Best Midsized Employers, Forbes, 2019 (#149 of 500)
• Top 150 Places to Work in Healthcare, Becker’s Hospital Review, 2019
• Top CEOs, Glassdoor, 2019 (#9 of 100)

Raise and Intuitive are Equal Employment Opportunity Employers. 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 all qualified applicants with arrest and conviction records in accordance with fair chance laws.

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