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/
[https://www.icumed.com/about-us/careers/investing-in-your-future/].
ICU Medical has consistently provided you with clinical innovations that help
solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in
2022, we are now a global market leader with a complete line of
clinically-essential IV therapy and high-value critical care products for
hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas
than ever. Our focus allows us to bring you:
Dedicated and non-dedicated IV sets and needlefree connectors clinically
proven to provide an effective barrier against bacterial transfer and
colonization.
The industry’s broadest IV smart pump offering covering large volume, pain
management, and ambulatory needs.
IV medication safety software providing full IV-EHR interoperability with the
highest customer satisfaction and compatibility with more EHR systems than
any other company.
Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that
all qualified applicants receive fair consideration for employment regardless of
race, color, nationality or national origin, ethnicity, sex, gender, religion or
belief, marital or civil partnership status, sexual orientation, pregnancy or
maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to
participate in the employment selection process, please contact us at
humanresources@icumed.com. We are committed to providing equal access and
opportunities for all candidates.
ICU Medical EEO Policy Statement
[https://www.icumed.com/media/lwkcbbam/icu-medical-eeo-policy-statement-2025.pdf]
Know Your Rights: Workplace Discrimination is Illegal Poster
[https://www.icumed.com/media/0mrnh211/know_your_right_2023-2.pdf]
ICU Medical CCPA Notice to Job Applicants
[https://www.icumed.com/media/1qwexl5a/icu-medical-job-applicant-privacy-notice-october-2024.pdf]