Regulatory Compliance Project Manager - Standards Management

Job Description Summary

Job Description

The Regulatory Compliance Project Manager - Standards Management position is primarily focused on monitoring standards, regulations and guidance documents in order to ensure continued compliance to the State of the Art.

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

• Keep abreast of all relevant standards, guidelines, and regulations, and hold quarterly meetings with stakeholders to communicate changes.
• Ensure gap assessments are performed by the appropriate stakeholder functions and documented per procedure.
• Manage projects, as necessary, to remediate gaps/maintain State of the Art compliance. This will include:

• Developing strategies to address gaps.
• Organizing and leading cross-functional teams and contract resources.
• Keeping schedules and, if necessary, budgets for remediation efforts.
• Coordinating with other ongoing documentation efforts, such as IVDR maintenance, to ensure efficient
• Completing all necessary documentation updates including, labels, IFUs, EU IVDR documentation, etc.
• Coordinating with International RA team to support ROW registrations.
• Coordinating change control and Notification of Change (NoC).

• B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry).
• Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree.
• Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations
• Demonstrated ability to lead cross-functional team to consistently to meet regulatory requirements and project timelines.

• Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
• Strong communication (written, oral) and project management skills.
• Able to handle multiple competing tasks with great attention to detail.
• Able to work independently to achieve objectives on or before schedule.
• Demonstrated cross-functional collaboration and teamwork skills including influencing without authority.
• Comprehensive knowledge of IVD regulations and standards.
• Current knowledge of European quality system standards, and requirements under EU IVDR and MDR preferred.