Associate II, Regulatory Affairs

Position Summary Provides regulatory support and expertise associated with global and US electronic publishing and submission of medical devices, including understanding the structure of the electronic submission, organization of the submission package and tracking of deliverables. With oversight, supports creation of global regulatory plans and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management. Essential Duties & Responsibilities Provides regulatory operations support working closely with the Global Regulatory Leaders and project teams. Identifies and communicates registration submission documentation. Maintains awareness of applicable regulations. Plans and organizes electronic registration packages for medical device products using the FDA’s eSTAR program. Prepares technical documentation registration packages in line with notified body requirements/formats and regional regulatory requirements and guidelines. Work with regional country Regulatory Affairs counterparts to evaluate and prepare documentation for electronic regulatory submission to ensure compliance with applicable regulations and guidelines. Knowledge & Skills Experience with electronic document publishing standards/formats, electronic and global regulatory submission publishing standards/formats. Excellent knowledge of publishing tools, global submission validation tools, Document Management systems, Toolbox, electronic submission gateways, MS Word, Adobe Acrobat including creating PDF hyperlinks and other support software. Review and organize critical documents associated with 510(k) eSubmitter electronic submission template, MDR and regional regulatory submissions, seeking guidance when necessary. Ability to convert PDF documents into Optical Character Recognition (OCR) documents, technical reports and other product related documentation for acceptability for electronic regulatory submissions. Identify registration documentation deficiencies and work with colleagues to accomplish resolution in a timely manner. Interpret global regulations/guidelines associated with electronic submissions and assure regulatory compliance, minimizing costs and delays. Exercise good judgment within policy and regulations. Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters. Acts independently on all routine issues, makes judgment and executes. Education and Experience Must be at least 18 years of age Bachelor’s Degree preferred in life sciences or Computer Science related subject. Minimum two years of experience in medical device (or equivalent) electronic submissions to the FDA, Notified Body, Health Canada and other regulators around the world. Able to organize technical documentation in the required electronic format and apply analytical and logical reasonings. Detail oriented, accountable for accuracy and quality in work and meeting multiple, simultaneous deadlines Ability to effectively prioritize workload and multitask with minimal supervision. Good interpersonal skills. Good oral and written communications skills. Demonstrated project management skills. Demonstrated critical thinking, contingency planning and negotiating skills. Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members. Travel Requirements: none Salary Range - $67,500-$96,750 The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location. ICU Medical provides a comprehensive total rewards package that includes: Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan A wide range of benefit options at affordable rates Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/ .