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Sr. Regulatory Affairs Specialist

Date: Aug 28, 2024

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :10689

About Teleflex Incorporated

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™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ 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 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

Teleflex is investing in our capability to drive material cost improvement opportunities as part of a strategic corporate approach to reversing recent trends in cost escalation and generating significant stakeholder value. Recent challenges in the market for materials used in the medical device industry, coupled with commercial and post-COVID environmental challenges, have placed significant pressure on the total cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on supporting material cost improvement projects that will shift this dynamic, reduce costs, and enhance product margins.

The Senior Regulatory Affairs Specialist will develop strategies and submissions for Material Cost Improvement Projects (CIP) and address issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interactions. This position will collaborate with the Commercial teams and other Regulatory functions to ensure projects align with the commercial objectives of the business.

Principal Responsibilities

• Provide Regulatory support for Material CIP projects, input and approval for new supplier changes.

• Identify key risks on Material CIP programs and communicate appropriately into the Program Lead to ensure all RA impacts are captured in each project.

• Serve as RA lead in the team to drive Material CIP programs

• Support the Program Lead in developing RA timelines in line with project charters and implementation plans

• Collaborate with the appropriate RA functional peers to establish key risks and develop program implementation plans

• Manage Technical Documentation

• Manage global regulatory impact assessments

• Review and assess change control activities for potential impact on current regulatory filings

• Work with Program lead to estimate the resources and participants needed to achieve project goals

• Proactively manage changes in project scope, identify potential risks, and devise contingency plans

• Manage stakeholder communication to ensure project status and/or related issues are effectively communicated

• Work with Quality, Operations, Engineering and other internal groups to investigate and recommend solutions to address potential regulatory issues

• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives

• 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

Education / Experience Requirements

• Engineering/Science qualification with 5+ years of working within R&D/QA/RA in a medical device environment.

• Minimum of 3 years experience in R&D, QA/RA, Validations – essential

• 3/4 years experience in Risk, Clinical and Biocompatibility – an advantage

• Excellent technical writing experience within a medical device environment - essential

• Attention to detail and accuracy – essential

• Fluent in English, both written and oral - essential

• Ability to work well under deadlines and pressure

• Problem solving skills for developing creative solutions and meeting objectives are required.

• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)

• Excellent analytical ability

• Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management

Specialized Skills / Other Requirements

• Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required

• Experience with Corrective Action, Manufacturing and Design Control concepts desired

• Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)

• Positive attitude and ability to operate and communicate effectively with multiple teams & leadership

• Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change

#LI-EB1

Working Conditions / Physical Demands

TRAVEL REQUIRED: 10 %

WORKING ENVIRONMENT:

☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2024 Teleflex Incorporated. All rights reserved.