Regulatory Affairs Specialist

Position Summary

Under the guidance of the Manager, Strategic 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 Product Management 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.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.   
 

Education / Experience Requirements

•    Bachelor’s degree, life sciences or related field preferred.
•    Preferred: 5 years regulatory experience; experience with regulated products and/or relevant skills/product types.
•    Knowledge and understanding of US and international medical device regulations, standards, and guidance documents.
 

Specialized Skills / Other Requirements

•    Must be a well-organized self-starter that takes the initiative for independent work with attention to detail and has an ability to follow written and verbal instructions. 
•    Manage assigned projects and related activities, propose market authorization strategies, effectively participate on cross-functional teams, and identify and solve mid-level problems. 
•    Basic understanding of, and ability to comply with, business and Regulatory Affairs ethical standards. 
•    Proficiency in MS Word, Excel, Power Point, and Outlook