Regulatory Affairs Specialist

Position Summary

Principal 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.
• Bring Regulatory Affairs questions/issues to the attention of Value Engineering and RA management and support identification of process improvements for regulatory affairs activities.
• 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.
• Adhere to and ensure compliance with Teleflex’s Code of Conduct, and all company policies, rules, procedures, and housekeeping standards.
• Support departmental SOP development and implementation and maintain regulatory files as required by departmental procedures.
• Review and approve Clinical Evaluation, PMCF, SSCP development and updates to ensure regulatory compliance.
• Adhere to the Code of Ethics for Regulatory professionals.
• Comply with Teleflex’s Code of Ethics and all company policies, rules, procedures, and housekeeping standards.
• Undertake effective OSH measures to ensure workplace compliance with the Occupational Safety and Health Act 1994 and other legislative requirements.
• Scope covers all Procurement – Value Engineering–related projects in APAC sites.

Education / Experience Requirements

Qualification    :    
Bachelor’s Degree in Engineering or equivalent

Experience    :    
Minimum 2 years Quality System or Regulatory experience in medical device industry.

Specialized Skills / Other Requirements