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We are looking for Regulatory Specialist II for our client in Portland, ME
Job Title: Regulatory Specialist II
Job Location: Portland, ME
Job Type: Contract
Job Overview:
We are looking for Regulatory Specialist II for our client in Portland, ME
Job Title: Regulatory Specialist II
Job Location: Portland, ME
Job Type: Contract
Job Overview:
- Responsible for supporting regulatory affairs activities for diagnostic products, including technical documentation, submissions, and compliance with international regulations.
- Works closely with cross-functional teams to ensure products meet regulatory requirements throughout their lifecycle.
- Bachelor s degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field.
- Minimum of 4 years of experience in a regulatory affairs role.
- Strong knowledge of IVDR and EU regulatory requirements.
- Excellent written and verbal communication skills.
- Strong time management skills with the ability to handle multiple projects.
- Ability to work independently and within a team.
- Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, and Visio.
- Experience in regulatory documentation and submission processes.
- Experience supporting product development and regulatory compliance.
- Experience maintaining regulatory records and approvals.
- Prepare technical documentation in accordance with IVDR requirements.
- Provide regulatory support for diagnostic product development and commercial products.
- Develop regulatory strategies for new and modified products to achieve approvals.
- Support regional teams with submissions, renewals, and amendments.
- Research and compile scientific and regulatory information for submissions.
- Maintain approvals, licenses, and authorizations for marketed products.
- Assess product, manufacturing, and labeling changes for regulatory impact.
- Develop internal procedures and regulatory tools.
- Conduct training sessions for stakeholders.
- Organize and maintain regulatory documentation and files.
- Ensure compliance with quality management systems and regulatory standards.
- Maintain professional communication with internal and external stakeholders.
- Experience in IVD or medical device manufacturing environments.
- Knowledge of global regulatory requirements.
- Regulatory affairs and compliance.
- Technical writing and documentation.
- Research and analysis.
- Communication and collaboration.
- Bachelor s degree in Biology, Chemistry, Biochemistry, Engineering, or a related field.