Manage multiple projects.
Maintain various tracking logs to ensure projects stay on schedule.
Escalate delayed activity to Regulatory Affairs Management.
Perform design history file searches in the electronic document management system.
Work with cross-functional teams to gather required documentation.
Review documents from various sources for completeness.
Compile regulatory submissions.
Perform miscellaneous tasks such as copying, scanning and filing.
Other various related activities.
Bachelor's degree with a minimum of 2 years direct Regulatory Affairs experience within the medical device field is required.
Microsoft Outlook & Calendar Management, Excel Spreadsheets, Microsoft Word and PowerPoint Presentations – able to create reports and manipulate data
Knowledge of Adaptive software (preferred)
Basic understanding of compliance and regulatory requirements
International experience outside of the US and EU is an asset.
Ability to work independently with limited supervision.
Strong analytical skills.
Flexibility – able to adapt to compliance cycle activities and demanding timelines.
Strong team player – will need to collaborate with Regulatory Affairs team, and other functional team members (on conference calls & in-house meetings).
Excellent written and verbal communication, and the ability to communicate effectively with all levels of the organization.