Associate II, Regulatory Affairs

RXinsider LTD.; Lake Forest (IL); On-site; USD 68,000 - 97,000; Full time

Benefits offered by this job

401(k) match

Tuition reimbursement

Paid time off

Job summary

ICU Medical seeks a Regulatory Operations Specialist to provide regulatory support for global and US electronic publishing and submissions of medical devices. You will assist with creating and maintaining submission packages, tracking deliverables, and ensuring full regulatory compliance.

You will collaborate with Global Regulatory Leaders and project teams, plan electronic registration packages (FDA eSTAR) and coordinate with regional counterparts to meet guidelines and timelines, supporting

Qualifications

• Bachelor's degree preferred in life sciences or Computer Science.
• Minimum two years of experience in medical device regulatory submissions to FDA/Notified Bodies.
• Experience with electronic document publishing standards and global submission formats.

Responsibilities

• Plan and organize electronic registration packages for medical devices using FDA eSTAR.
• Prepare technical documentation for submissions according to regional requirements.
• Collaborate with regional Regulatory Affairs to ensure regulatory compliance and timely submissions.

Skills

Regulatory publishing

Document management

FDA eSTAR experience

Global regulatory submissions

Education

Bachelor's degree preferred in life sciences or CS

Minimum 2 years of medical device regulatory submissions experience

Tools

Publishing tools

DMS/Toolbox

PDF/Adobe Acrobat

Submission gateways

MS Word

Job description

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/ .

About Us

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 [e-mail]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

ICU Medical CCAA Notice to Job Applicants