- Develop regulatory strategies for new products throughout the process, from development to launch, for moderate-complexity projects and assure collection of appropriate data for regulatory submissions and regulatory compliance.
- Review and assess change control activities for potential impact on current regulatory filings.
- Ensure compliance with design controls, review design documentation to ensure that it follows the regulatory requirements, and provide regulatory expertise and oversight to design teams.
- Interpret existing regulations and guidance documents withing regulatory department and on project teams. Understand and communicate regulatory requirements and what they mean to the organization and management.
- Identify risk factors and contingency planning for assigned projects.
- Interact with regulatory authorities during the development and review process to ensure submission approval, as well as during audits to mitigate potential risks.
- Interface, as needed, with the FDA, Notified Bodies, or other national health agency regarding new products and significant changes to products.
- Assume full responsibility for project submissions from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside of the U.S.
- Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of responses to regulatory agency questions and/or requests for information.
- Review and approve all labeling (product, advertising, and promotional) verbiage and evaluate for any regulatory impact.
- Apply understanding of the quality systems to job activities and projects.
- Participate in training RA team members and others on compliance matters.
- 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 standards.
- Minimum of 2-3 years of regulatory affairs experience in a regulated environment is required.
- Bachelor's degree in a science or engineering field is preferred.
- Basic understanding of, or experience with, medical devices with electrical capabilities is a plus.
- Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices is highly preferred.
- RAC certification is a plus.
- Strong analytical and critical thinking skills.
- Strong communication skills (both verbal and technical writing)
- Strong organizational and time management stills with high level of personal and professional integrity and trustworthiness.
- Strong work ethic with the ability to work independently, manage multiple projects with minimal direction, and meet deadlines.
- Orientation to teamwork, problem solving, customer focus, and commitment to quality.
- Basic understanding of, and ability to comply with, business and Regulatory Affairs ethical standards.
- Proficient in MS Word, Excel, Power Point, and Outlook required.
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Regulatory Affairs Specialist - Morrisville, United States - Teleflex
Description
Expected Travel:Up to 10%
Requisition ID: 10017
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 visitGlobal 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 the Surgical portfolio.
Submissions will be at a moderate to complex level and will relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction.
The incumbent is also responsible for staying abreast of evolving global regulatory requirements.Principal Responsibilities
Education / Experience Requirements
Specialized Skills / Other Requirements
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:or
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
