Full Job Description
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
• 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.
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.
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.
