Sr. Regulatory Affairs Specialist

Expected Travel: None

Requisition ID: 9845

 

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

The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for blood products and biologics. Submissions will be at moderate to complex levels. 

Principal Responsibilities

•    Assume full responsibility for project submissions, including BLA, IND, 510(k) premarket notifications, and other documentation from guidance/strategies/authoring/obtaining approvals. 
•    Review and approve all labeling (product, advertising, instructions for use, and promotional) verbiage to ensure regulatory compliance and substantiated claims.
•    Interface with the FDA, applicable notified bodies, or other national health agencies regarding the development and review process to ensure submission approval and during audits to mitigate potential risks for new products and significant changes as needed.
•    Prepare regulatory strategies for intermediate to moderate-complexity projects for new products and product line modifications/extensions from development to launch.
•    Interpret existing regulations and guidance documents within the regulatory department, the business, and project teams. Understand and communicate regulatory requirements and what they mean to the organization and management.
•    Analyze changes for their impact on regulatory requirements and current filings, communicate the impact to the team, and complete the required documentation for decision.
•    Review and approve test protocols and reports (DVT, biocompatibility, sterilization, packaging, shelf-life, etc.) to meet regulatory requirements.
•    Research, prepare, and present training to employees (peers and management) on market authorization trends, promotion and advertising, and other relevant regulatory topics with business impact.
•    Identify regulatory risk factors and contingency planning for assigned projects.
•    Prioritize projects independently based on department and corporate objectives.
•    Participate in product development through involvement in project team meetings, including risk assessment(s) as applicable.
•    Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of responses to regulatory agency questions and requests for information.
•    Apply understanding of the quality systems to ensure regulatory requirement compliance and to perform job activities and projects.
•    Bring Regulatory Affairs questions/issues to the attention of RA management. Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping. 

Education / Experience Requirements

•    A bachelor’s degree in a science or engineering field is preferred.
•    Five years of relevant regulatory experience required. Ideal candidates will have experience with commercialization efforts, creating/reviewing labeling and advertising/promotional materials for pharmaceuticals/biologics/medical devices, authoring, reviewing, and approving regulatory applications, analytical test methods, and justifications for specifications.
•    Experience with combination and biologic products is preferred 
•    Experience with design and manufacturing product transfers is preferred
•    Experience with facilitating both internal and external audits, i.e., FDA is required.
•    Proven history of successful domestic submissions. 
•    RAC certificat