Field Compliance Summer Associate supporting agronomic research and development in canola at BASF's Agricultural Solutions team in Alberta. Involves data collection, crop monitoring, and field logistics.
About the role
- Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
Responsibilities
- Generate and maintain Technical Files/Technical Documentation and regulatory submissions to U.S. FDA, EU-NB, and Health Canada for all Value Engineering projects
- Ensure the files comply with relevant regulations and standards
- Support Value Engineering in change control activities/product development for potential impact on current regulatory filings for U.S. FDA, EU-NB, and Health Canada
- Prepare regulatory assessments/submissions as appropriate
- Assume full responsibility for project submissions, including guidance, strategies, authoring, and obtaining approvals (including 510(k)) premarket notifications, EU MDD/MDR Technical Files, and documentation required for registration/licensure of products under Value Engineering
- Review and provide feedback on risk management assessments and design control deliverables to ensure compliance with regulatory requirements
- Develop timelines, coordinate receipt of technical information from appropriate sources, and manage preparation of responses to regulatory agency questions and requests for information
- Identify risk factors and develop contingency planning for assigned projects, communicating to RA management as appropriate
- Review and approve all labeling (product, advertising, and promotional) verbiage and evaluate for regulatory impact
- Ensure all operations comply with applicable licenses and are updated according to regulations and directives
- Apply knowledge of quality systems to job activities and projects by adhering to established and evolving internal requirements
- Monitor evolving global regulations regarding submissions, practices, and procedures to support regulatory processes
- Support product registration, tenders, license applications, and maintain the regulatory database as appropriate
Requirements
- Minimum 2 years Quality System or Regulatory experience in medical device industry
- Bachelor’s Degree in Engineering or equivalent
Benefits
- health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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