What are the responsibilities and job description for the Regulatory Specialist II position at Cynet Systems?
We are looking for Regulatory Specialist II for our client in Portland, ME
Job Title: Regulatory Specialist II
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.
Requirement/Must Have:
- 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:
- Experience in regulatory documentation and submission processes.
- Experience supporting product development and regulatory compliance.
- Experience maintaining regulatory records and approvals.
Responsibilities:
- 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.
Should Have:
- Experience in IVD or medical device manufacturing environments.
- Knowledge of global regulatory requirements.
Skills:
- Regulatory affairs and compliance.
- Technical writing and documentation.
- Research and analysis.
- Communication and collaboration.
Qualification And Education:
- Bachelor s degree in Biology, Chemistry, Biochemistry, Engineering, or a related field.