Associate I, Regulatory Affairs – 24300935-8088

This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12282233 Position Summary

The Regulatory Affairs Associate will assist with 510(k) submissions,
International Licensing and Submissions, and respond to routine
regulatory queries for information and documents.

The Regulatory Affairs Associate will also complete International
product registrations and export certifications as requested by ICU
Medical distributors and international regulatory agencies.

Essential Duties & Responsibilities

Assist with current technical files and declarations of conformity in
accordance with MDD. Identify and act upon activities needed to remain
in compliance with essential requirements of the MDD.

Stay at the forefront of evolving regulatory requirements and be
proactive in maintaining compliance

Prepare and review Regulatory Assessments; formally document the
rationale for circumstances which justify not filing submissions; notify
management when notification is required.

Assist with and maintain facility registrations, device listings, and
appropriate licenses. Ensure that all ICU facilities are registered with
appropriate State, Federal, and International regulatory agencies such
as the Federal Food and Drug Administration, Canada, SUKL, etc. Ensure
that all products manufactured, distributed or packaged by ICU are
listed with the appropriate agency as required.

Respond to customer queries and questionnaires for regulatory
information

Work on special projects as they arise

Knowledge, Skills & Qualifications

– Excellent interpersonal skills and the ability to work in a team
environment
– Strong organizational skills and a high level of attention to detail
– Excellent verbal and written communication skills; English language
– Ability to prioritize key business objectives and respond quickly to
changing priorities
– Able to multitask and work in a fast-paced environment
– Proficient in Excel, Word and Outlook; able to work in a variety of
databases and create reports and analyses

Education and Experience

– Bachelors degree from an accredited college or university required
– Minimum 0-2 years of regulatory and medical device experience, or
equivalent
– Must have working knowledge of applicable regulatory requirements
– Basic experience in regulated manufacturing
– Experience in Quality Systems Auditing

Travel Requirements

Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

While performing the duties of this job, the employee is regularly
required to talk or hear. This is largely a sedentary role; however,
some filing is required. This would require the ability to lift files,
open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment. This role
routinely uses standard office equipment such as computers, phones,
photocopiers, filing cabinets and fax machines.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All
qualified applicants will receive consideration for employment without
regard to race, color, religion, sex, sexual orientation, gender
identity, national origin, or protected veteran status and will not be
discriminated against on the basis of disability.