Sr. Regulatory Affairs Specialist

Expected Travel: Up to 10%

Requisition ID: 9252

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

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

Under the guidance of the Director, Regulatory Affairs, support the Strategic Manufacturing group to coordinate completion of global submissions and registration documents in support of manufacturing transfer projects and track their progress against planned timelines. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The candidate is required to work effectively with cross-functional virtual groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances/approvals. The candidate is also responsible for staying abreast of evolving global regulatory requirements. 

Principal Responsibilities

•    Develop and complete regulatory planning activities for the applicable strategic manufacturing projects. 
•    Review and assess strategic manufacturing activities for potential impact on current regulatory findings.
•    Clearly communicate regulatory requirements for the strategic manufacturing projects to the project managers and program manager. 
•    Ensure compliance with design controls and good manufacturing practices. 
•    Apply understanding of the quality systems to job activities and projects.
•    Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution, and closure of the projects.
•    Assist in producing new or revised global medical device submissions in the format consistent with the governing SOP’s.
•    Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
•    Liaise with Business Unit Regulatory Affairs functions to track and monitor regulatory submission timelines, facilitate recurring meetings, and provide meeting minutes.
•    Manage regulatory specific project deliverables and interdependencies; communicate risks or delays in a timely manner.
•    Identify risk factors and contingency planning for assigned projects.
•    Brings Regulatory Affairs questions/issues to the attention of RA management.
•    Interface with various departments to collect and organize required documentation materials.
•    Keep abreast of relevant domestic, European, and other international regulatory requirements for medical devices.
•    Mentor junior staff in the application and execution of regulatory activities and business processes.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.   
 

Education / Experience Requirements

•    Degree; desired four-year college degree in Science or Engineering disciplines.
•    Minimum 8 years’ experience working within medical device industries; 3+ years with Class II or higher registrations.
•    Knowledge and understanding of US and international medical device regulations, standards, and guidance documents.
 

Specialized Skills / Other Requirements

•    Excellent verbal and written communication skills – essential
•    Attention to detail and accuracy – essential
•    Complex problem-solving skills for developing creative solutions and meeting objectives independently and as part of a team - essential
•    Experience participating in several projects concurrently
•    Self-driven and ability to work independ