Regulatory Operations Specialist
About The Position
The Regulatory Operations Specialist provides regulatory and operational support for new country product launches, global new site registrations and site renewals for Intuitive and third-party sites. The role prepares standardized technical documentation for medical devices for global submissions and assists with facility transfers and manufacturing-line transfer projects. The specialist works cross-functionally with corporate and global departments to improve regulatory tools and processes. Responsibilities include drafting and updating procedures and work-process tools such as templates, forms, SOPs, work instructions, checklists, and trackers; reviewing procedures and identifying improvements based on data and user experience; collaborating with development teams on regulatory tools and applications; and supporting audit preparation.
Requirements
- Some relevant experience working in a medical device company.
- A bachelor's degree in a listed science, math, engineering, or medical field with 4–5 years of experience; or a master's degree or foreign equivalent in Biomedical Engineering, Regulatory Science, Life Science, Pharmacy, or a related field with 1–2 years of experience.
- 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.
- Motivation to excel and work in a team environment.
- Excellent customer service and interpersonal skills.
- Ability to deal with problems and issues professionally.
- Ability to understand the implications of work and make recommendations for 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
- Preferred 1–2 years of experience working in regulatory operations or software development.
- Experience writing technical specifications, user requirements, or functional requirements.
- Essentials of Data Structure and Algorithms, Software Design and Architecture.
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 across 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 department 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 design tools and applications for regulatory processes and workflows.
- Support the audit team in preparing documents for audits.
Benefits
- Market-competitive compensation packages inclusive of base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
