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Regulatory Affairs Specialist

Company: Intuitive
Location: Santa Clara
Posted on: January 10, 2022

Job Description:

8 Month contract opportunity with potential for extension or permanent hire
Compensation: $70-95/hr
Location: 1388 Kifer Rd., Sunnyvale, CA 95051
7+ years of related experience required

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.

Primary Function of Position:
Regulatory registrations/filings in the Indirect EMEIA region and Regulatory operations support.

Roles & Responsibilities:
Plans, organizes, prepares and maintains regulatory registrations and filings that are supported by distributors
Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
Monitors regulatory changes in indirect markets to ensure compliance to local regulations are met and partner with distributors to align
Interprets regulatory documents and interfaces either directly with the regulatory body or indirectly through a distributor or consultant for timely approval of products /product changes
Communicates registration strategy with sales & marketing stakeholders Additional activities
Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes
Supports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements
Assists and supports other employees, teams and field personnel as necessary
Performs other tasks and manages projects as assigned

Skills, Experience, Education, & Training:
7+ years of significant experience in similar function
Knowledge of emerging market regulations
Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
Ability to be effective in complex projects with ambiguity and/or rapid change
Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
Good team skills with ability to collaborate, influence and lead others
Excellent interpersonal skills, ability to work with customers and authorities
Orientation for detail work product, with emphasis on accuracy and completeness
Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile, CRM and SAP a plus
A Bachelor's or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
Strong knowledge of Quality Management System requirements to ISO 13485 required and broad understanding of what it takes to work in a regulated environment
Fluent in written and spoken English, ideally possessing other language skills

Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise Recruiting, 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.

Keywords: Intuitive, Santa Clara , Regulatory Affairs Specialist, Other , Santa Clara, California

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