**About Teleflex Incorporated****Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.**Position Summary**:**Principal Responsibilities**:- Manage Technical Documentation and regulatory submissions to US-FDA, EU-NB, Health Canada- Use technical writing skills to clearly describe technical information- Review and assess of change control activities for potential impact on current regulatory filings and prepare regulatory assessment/strategy as appropriate.- Manage updates to global regulatory procedures and maintenance of Regulatory procedures to ensure continued compliance.- Ensure continual Quality System compliance by adherence to established and evolving internal requirements.- Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management as they relate to registration and commercialization of medical devices to impacted countries.- Support Regulatory inspections at the site as directed.- Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.- Review and approve product labelling to ensure compliance to Regulations of impacted countries.- Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives- Conduct assigned projects by superior to ensure regulatory compliance- Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements.**Education / Experience Requirements**:Qualification:Degree in Science (Material, Polymers, Biology, Health Sciences or Chemistry or Quality Management System)Experience:Minimum 2 years' working experience in a manufacturing environment.**Specialized Skills / Other Requirements**:**Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.****Teleflex is an equal opportunities employer
