Regulatory leadership opportunity available in Raleigh-Durham, NC's Research Triangle Park for a leading medical device organization. Direct interaction with regulatory agencies shaping the sucess of submissions and audits at Teleflex.
The Asia – Japan – Latin America group is responsible for the sales and marketing of Teleflex’s medical products in seventy-four (74) countries across three continents, encompassing over half the world’s population.
The group is headquartered in the Research Triangle Park, North Carolina in the United States of America, with established affiliate offices in China, India, Japan, Mexico and Singapore. Teleflex manufacturing facilities are strategically placed across the region.
The AJLA region has provided significant growth over the last several years and is poised and ready to partner with you in patient care.
The Sr. Regulatory Affairs Specialist will lead a product focused team of Regulatory Specialists and Associates to develop strategies for complex project and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction.
As a leader in the Regulatory team, mentoring and development of staff members will be an important aspect of the role.
•Conduct appropriate research to develop strong regulatory strategies for new products.
•Working with Quality, Operations, Engineering and other internal groups investigate and recommend solutions to address potential regulatory issues.
•Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
•Participate in Risk Management assessments.
•Review and approve all Labeling (product, advertising and promotional) verbiage.
•Assist in regulatory due diligence process.
•Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
•Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
•Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
•Bachelor’s degree in a science or engineering field. Equivalent experience may be acceptable in lieu of a degree.
•3 years with Class I or II medical devices.
•3 to 5 years of overall Medical Device Regulatory Affairs experience.
•Prior leadership role.
•Able to travel domestically and internationally.
•Regulatory Affairs Certification (RAC).
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety