Regulatory Operations Specialist SMT

Position Summary

In support of Strategic Manufacturing Transfer (SMT) programs, this role will maintain current worldwide regulatory registrations, submit information to regional partners for international product registrations and ensure regulatory requirements are met for quality systems.

Principal Responsibilities

• Support preparation of International product registrations for all Teleflex products in scope of relevant SMT programs.
• Create, manage, and maintain databases to track projects and product registrations.
• Facilitate regulatory assessment completion for product changes (Teleflex products or Purchased Finished Goods/Devices) in collaboration with international regulatory teams.
• Communicate impact to project team and/or Product Management RA and complete required documentation for decision.
• Prepare Certificates to Foreign Governments and document legalization.
• Prioritize and manage projects independently based upon department and corporate objectives.
• Maintain and manage related quality system procedures to ensure continued compliance.
• Participate in regulatory agency inspections and audits, as needed.
• Provide other departmental support as requested by immediate supervisor.
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• File and archive regulatory documents, submissions, reports, etc.
• Respond to requests for regulatory data, such as, tenders, etc.
• Act as mentor to junior staff, where appropriate, providing training and on the job guidance.

Education / Experience Requirements

• Proficiency in English for business conversations.
• Bachelor’s Degree in Pharmaceutical, Chemistry or Engineering or related.
• 4 years of experience in Regulatory Affairs, Medical Devices.

Specialized Skills / Other Requirements

• Well-organized with attention to detail.
• Follows written and verbal instructions.
• Takes initiative; is a self-starter.
• Able to coordinate and prioritize activities.
• Database skills.
• Good verbal and written communication skills.
• Efficiently proofreads technical documentation for consistency and formatting.
• Good intra- and interdepartmental collaboration skills.
• Identifies and solves basic problems.