Regulatory Affairs Specialist

1 week ago

Sheboygan, Wisconsin, United States Rockline Industries Full time
Regulatory Affairs Coordinator

We are seeking a highly detail-oriented and proactive Regulatory Affairs Coordinator to join our team at Rockline Industries. As a key member of our regulatory compliance team, you will play a pivotal role in maintaining our company's compliance with ever-evolving regulatory requirements.

Key Responsibilities:
  • Maintain and update regulatory data within our systems, ensuring accuracy, completeness, and timeliness of information.
  • Collaborate with suppliers and vendors to obtain necessary regulatory documentation and updates.
  • Serve as the primary point of contact for internal departments and external partners regarding regulatory data inquiries and requests.
  • Coordinate with regulatory affairs, quality assurance, and other relevant departments to gather required regulatory information for input into our systems.
  • Monitor regulatory changes and updates, ensuring that regulatory data within our systems is kept up-to-date and compliant with current regulations.
  • Conduct regular audits and quality checks of regulatory data to identify discrepancies, errors, or gaps and take corrective actions as needed.
  • Generate reports and metrics related to regulatory data management for internal and external stakeholders.
  • Stay informed about industry best practices and emerging technologies related to regulatory data management to enhance efficiency and effectiveness.
Requirements:
  • Bachelor's degree in a relevant field such as regulatory affairs, life sciences, or a related discipline required; or in lieu of degree, we will consider candidates with a combination of education and relevant experience.
  • 0-3 years of experience in comprehending legislative and regulatory frameworks, including but not limited to FDA, EPA, and TSCA guidelines.
  • Requires excellent attention to detail, strong time management and communication skills, and a willingness to take the lead.
  • Strong understanding of Microsoft Office (Excel, Word, PowerPoint, etc.) and Adobe Acrobat Pro.
  • The ability to manage and organize large volumes of data effectively.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
  • Proficiency in using regulatory information systems, databases, and software applications.
  • Knowledge of regulatory requirements and standards relevant to our industry and products.
  • Ability to work independently and prioritize tasks to meet deadlines in a fast-paced environment.
  • Strong analytical and problem-solving skills, with the ability to identify and resolve data management issues.
  • Commitment to continuous learning and professional development in the field of regulatory affairs and data management.
  • Working knowledge of Microsoft office suite and Adobe Acrobat Pro.

We are an equal opportunity employer and welcome applications from diverse candidates. Please note that we will not discriminate against employees or applicants based on their pay or the pay of other employees or applicants.

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