Sr. Regulatory Affairs Associate

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, Quik Clot™, Rüsch™, Uro Lift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare.

For more information, please visit .

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.

The Sr Regulatory Affairs (RA) Associate will be responsible for a variety of regulatory activities to meet submission, departmental, and quality system compliance requirements. The Senior RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k) s, Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory deliverables, take primary authorship responsibility for market authorization maintenance activities (e.g., renewals and periodic updates), and lead departmental activities supporting product release, regulatory intelligence, and submission metrics.

This position will interact with business unit customers to support global submissions.

• Support 510(k) s and associated documents, EU MDR submissions, and Health Canada license applications and amendments.
• Prepare electronic submission compilations for the United States (US), Canada, and EU markets.
• Update and maintain EU MDR technical files and documentation to ensure continued compliance.
• Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc.
• Support regulatory requests for global markets.
• Update and maintain regulatory trackers, databases, and submission files.
• Apply understanding of the quality systems to job activities and projects.
• Update and maintain market authorization and regulatory submission/correspondence files.
• Support IPN and GTIN requests.
• Execute SAP ship control transactions to release, hold, or end product commercialization for the US and Canadian regions.
• Generate trending and metric reports, e.g market authorization review times, change order review times, project time tracking. Maintain submission trackers.
• Coordinate worldwide submission change notifications and regulatory impact assessments. Communicate the impact and support required for regulatory activities.
• Update applicable quality system procedures to ensure continued compliance

• A bachelor’s degree, preferably in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.
• Minimum 2 years of medical device regulatory experience or equivalent.
• Basic experience with preparing 510(k) submissions, EU MDR Technical Documentation Files, or Health Canada license applications.
• Basic experience with change control process and assessments.
• Basic experience working with cross-functional teams.

Preferred:

• Basic medical device global regulatory knowledge base (outside of the US, EU, and Canada): submissions, marketing approvals, licensing, registrations, and renewals.
• Knowledge and…