Overview
On Site
$$40.28hr - $45.28hr
Contract - W2
Contract - to 08/18/2026
Skills
Regulatory Affairs Associate
Job Details
Job Description:
Pay Range: $40.28hr - $45.28hr
Responsibilities:
Pay Range: $40.28hr - $45.28hr
Responsibilities:
- Will introduce a new process to centralize post-approval addendum labeling activities for the full Vascular medical device portfolio.
- 3-5 years of experience, understanding quality, project management experience is plus, Addendum labeling is needed.
- (No fresh grads/ minimum of 3years experience) Experience in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.
- Experience working with policies and procedures impacting documentation and documentation practices.
- Communication skills, cross-functional team, problem solver, SAP MD and other relevant software.
- Hands-on experience with addendum labeling and labeling requests and language requirements, which are critical for this position.
- (International experience is preferred) Strong knowledge of regulatory requirements for medical device labeling.
- Proficiency in SAP MD and other relevant software systems.
- Familiarity with Adobe Acrobat Pro, SAP, and other content management systems.
- Substantial experience coordinating and executing project activities in a highly regulated industry.
- Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
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