Description 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 Bachelor's 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.