Regulatory Affairs Specialist

Teleflex is a global provider of 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, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.

The Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role.

Coordinates and prepares moderately complex regulatory submissions, including 510(k) premarket notifications, EU MDD Technical Files, and/or other documentation required for registration/licensure of products outside the U.S. Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products. Provides a regulatory expertise and oversight to design teams. Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices. Insures compliance with design controls and reviews design documentation to insure regulatory requirements are met. Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. Participates in business interactions and negotiations with regulatory agencies on premarket submission requirements, formats, labeling claims, etc. Monitors FDA and other government agency laws and regulations through websites and publications. Provides support to more senior RA staff, and performing other related duties Brings Regulatory Affairs questions/issues to the attention of RA management.

•Bachelor’s degree in a science or engineering field. 1-2 years with Class I or II medical devices •2 -3 years of overall Medical Device Regulatory Affairs experience, Domestic and International •Able to travel domestically