Regulatory Operations Specialist

Intuitive • Sunnyvale, CA

4d

About The Position

Provide regulatory and operational support for new-country product launches, global new-site registrations and renewals for Intuitive and third-party sites, and facility and manufacturing-line transfers. Prepare standardized technical documentation for medical-device submissions worldwide. Work across corporate and global teams to improve regulatory tools and processes, and draft, update, and review procedures and process tools to promote efficiency and identify improvements. Collaborate with development teams on tools and applications for regulatory workflows and support audit preparation by helping prepare documents.

Requirements

• Relevant experience working in a medical-device company.
• Bachelor’s degree in a listed science, math, engineering, or medical field and 4–5 years of experience; alternatively, a master’s degree or foreign equivalent in Biomedical Engineering, Regulatory Science, Life Science, Pharmacy, or a related field and 1–2 years of experience.
• Knowledge of the essentials of data structures and algorithms, and software design and architecture.
• Strong attention to detail and ability to follow procedures, processes, and instructions.
• Good written and oral communication and organizational skills.
• Ability to perform multiple tasks in a fast-paced environment and work in a team environment.
• Excellent customer service and interpersonal skills, and ability to handle problems professionally.
• Ability to understand the implications of work and recommend process improvements.
• Excellent skills in MS Word, Excel, and Outlook, and capacity to learn additional software.
• Ability to identify and solve basic problems.

Nice To Haves

• 1–2 years of experience in regulatory operations or software development.
• Experience writing technical specifications, user requirements, or functional requirements.

Responsibilities

• Provide regulatory and operational support for new-country product launches, global new-site registrations, and site renewals for Intuitive and third-party sites.
• Prepare standardized technical documentation for medical devices to be used in global submissions.
• Assist with Intuitive facility transfers and manufacturing-line transfer projects.
• Communicate and collaborate across corporate and global departments to improve regulatory tools and related processes.
• Draft and update regulatory procedures and work-process tools, including templates, forms, SOPs, work instructions, checklists, and trackers.
• Review procedures and identify process improvements based on data and user experience.
• Collaborate with development teams to help design tools and applications for regulatory processes and workflows.
• Support the audit team by preparing documents for use in audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level