Job Details
Posted 22 September, 2026
Job Id: 631141
Regulatory Affairs Associate I
Job Description
Pay range: 35-45/hr
*depending on exp
Description:
Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global products.
Top three to five technical skill requirements-
-Familiar with USA and OUS device regulations (specifically EU device regulations)
-Experience with RA strategy development
-Experience with working with Cross functional team members
-Experience with interaction with external Regulators (FDA, TUV)
-Experience with working with medical devices
Essential Duties and Responsibilities
* Supports regulatory project plan execution
* Maintain awareness of regulatory requirements and ensure continued learning
* Maintain regulatory files in a format consistent with requirements
* Participate as an active team member of project teams as required
* Compile and prepare responses to questions from regulatory authorities according to plan
* Edit and proofread regulatory documentation
* Assist in preparation and review of labeling, SOPs, and other departmental documents
* Compile under supervision regulatory documents for submission
* Track status and progress of regulatory documentation
* Understand Regulatory Affairs’ position in small project teams
Qualifications
* Knowledge of regulations
* Scientific knowledge
* Administrative and project management skills
* Ability to contribute to multiple projects from a regulatory affairs perspective
* Ability to multitask and prioritize
* Interpersonal and communication skills
* Technical system skills (e.g. word processing, spreadsheets, databases, online research)
* Proofreading and editing skills
Education and/or Experience
* Bachelors degree or country equivalent in a relevant scientific discipline
* Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification
* Regulatory experience preferably within a healthcare environment
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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