Regulatory Affairs Team Lead

Position Summary

Responsible for leading regulatory staff in support of product registrations, regulatory strategies, managing submissions and interactions with third parties and/or various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the regions as they impact operational support.
•    Support Product Management and Regional RA groups in maintaining current worldwide regulatory registrations 
•    Maintain the release of product distribution as part of product commercialization worldwide 
•    Ensure regulatory requirements are met per quality management systems
•    Assess data from Regulatory Impact Assessments (RIA) and support regional RA to ensure global market authorization needs
•    Prioritize and manage projects independently based on corporate objectives.
 

Principal Responsibilities

•    Lead and manage day to day activities and regulatory staff
•    Support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products globally
•    Partner with Regional RA teams for the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of submissions for new products, amendments of approved products and submissions that support the maintenance of existing licenses
•    Review and evaluate issues which may create regulatory or business obstacles and investigate solutions
•    Support the preparation of responses to regulatory agency questions and/or requests for information, as needed
•    Assist in regulatory due diligence processes, as needed
•    Support and participate in regulatory inspections, as needed
•    Support product recalls in collaboration with Product Management and Regional RA groups, as needed 
•    Communicate regulatory activities and issues to key stakeholders, which may include Business Unit and Regional leadership
•    Apply understanding of the quality systems to job activities and projects
•    Train, develop, and mentor staff as appropriate 
•    Assist with SAP Ship Control Table (SCT) maintenance activities and supporting Agile workflow. Execute SAP SCT transactions to release, hold or end product commercialization in coordination with Product Management and Regional RA as applicable
•    Assist with the maintenance of Market authorization information in appropriate spreadsheets/databases  
•    Support tracking of Metrics
•    Provide inputs to Supply and Demand Planners as needed
•    Support Regulatory procedural consolidation/updates while maintaining QS compliance
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards
 

Education / Experience Requirements

•    Bachelor’s Degree in a relevant field 
•    7+ years’ experience in a highly regulated environment such as medical device, pharmaceutical, or other highly regulated environments  
•    Minimum of 3 years regulatory affairs/compliance leadership experience
 

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
•    Basic database, Excel, Microsoft Word, SAP, and Agile 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
 

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