Participate in multidisciplinary teams and communicate regulatory requirements effectively
Provide regulatory input to product lifecycle planning
Obtain and evaluate regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices
Conduct appropriate research to develop strong regulatory strategies for new products
Determine issues that may create regulatory obstacles and investigate solutions
Prepare and submit applicable regulatory documentation, as required (with focus on the US, EU and Canadian markets) and/or compile necessary documentation as requested by International Regulatory Affairs personnel
Monitor progress of submission reviews and interact with regulatory agencies, as appropriate
Participate in risk management assessments
Review and approve product labeling, advertising, and promotional information for regulatory compliance
Assist with SOP development and implementation
Maintain regulatory information systems
Support device import/export and distribution control activities
Support regulatory compliance initiatives
Monitor the impact of changing and evolving global regulations on submissions, practices, and procedures, and communicate to appropriate personnel
Other duties as assigned by the Regulatory Affairs management team
Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping standards

Associate or Bachelor’s degree, preferably in the science or engineering disciplines
Must have 2-5 years in a medical device organization, preferably in regulatory affairs
Previous US, Canadian, and EU submissions experience preferred
RAC certification preferred
Ability to apply business and Regulatory Affairs ethical standards; analytical and critical thinking skills
Proficient in Microsoft Office Suite

Regulatory Affairs Specialist

Key skills