Senior Regulatory Affairs Specialist - NPD Clinical Studies

Job Description

Primary Function of Position
This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in
global regulated markets for complex products.
Essential Job Duties
• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Lead regulatory submissions, agency communications and strategy for the US and Canada for complex product approvals.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Coordinate with OUS global regulatory teams for product registrations and variations.
• Review, approve, and update project documentation.

Qualifications

Required Experience and Education
• 6–8 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of education
and experience.
Required Knowledge, Skills and Abilities
• Agency negotiation and strategic planning proficiency.
• Expertise in global regulatory requirements and registration processes.
• Advanced project leadership and communication skills.
• Technical documentation review and approval capabilities.
• Experience with audits, submissions, and training.

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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [email protected].

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.

Min. Salary Region 1: 151700 USD
Min. Salary Region 2: 128900 USD
Max. Salary Region 2: 185600 USD
Max. Salary Region 1: 218300 USD