Regulatory Affairs Associate
Regulatory Affairs Associate
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs import labels and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.
Responsibilities:
- Develop and design compliant labeling including IFUs and international labels.
- Coordinate cross-functional teams and manage multiple labeling projects.
- Implement changes per international regulatory guidelines.
- Fill out forms revue redlines and submit packages to the labeling team.
- Track labeling change requests and maintain documentation for audits.
- Monitor global regulatory trends and update internal procedures.
- Support quality system improvements and KPI reporting.
Requirements:
- Bachelors degree in Regulatory Affairs Biomedical Engineering or related field.
- 4 years in regulatory/quality operations within a regulated industry.
- Experience with labeling design document control and regulatory submissions.
- Strong knowledge of FDA and international device labeling regulations.
- Proficiency in SAP Adobe Acrobat and MS Office.
- Experience with Class III implantable medical devices.
- Hands-on with PMA supplements change assessments and audit preparation.
- Strong project coordination and stakeholder communication skills.
Employment Type
Full-time
