Posted in Other 13 days ago.
Location: Mansfield, Massachusetts
Expected Travel: Up to 25%
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 visit teleflex.com.
OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Responsible for evaluating gaps, preparing gap assessments and updates to technical documentation that are required to meet the EU MDR requirements. Participate and interface with teams to address and execute the transition from the Medical Device Directive to the Medical Device Regulation. Products will include the following classifications, i.e. Class I, IIb and III. The position will require basic knowledge to be capable of interfacing and assessing documents from various departments such as Clinical Affairs, R&D and BU Regulatory Affairs.
• Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements.
• Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability strategy, protocols & reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements, declarations of conformity, clinical evaluation reports and clinical data.
• Support the collection and provision of data required to submit to EUDAMED.
• Work with Project Manager & Business Unit (BU) lead to determine implementation plan to complete updates to documentation
• Work with BU Regulatory & MDR program work stream leads to ensure technical documentation update timelines are aligned.
• Participate in regulatory impact assessments as they relate to the MDR and relay the information to product specific RA team member and/or design teams.
• Identify use of appropriate International standards
• Work in coordination with MDR project management to monitor MDR government agency laws and regulations through websites and publications.
• Provide guidance to junior members of the Regulatory Affairs staff as related to the MDR project
• Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team and Business Unit Leads
• Report out for specific BU project status to Core Team and potentially MDR Steering Committee
• Determine issues which may create regulatory obstacles; investigate and propose solutions
• May serve as MDR RA team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices
• May support new product development teams to assure collection of appropriate data for MDR regulatory submissions and compliance
• Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Education / Experience Requirements
• Minimum of a Bachelor's degree required. Focus in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology, preferred.
• Minimum of 2 years' experience working in a FDA or ISO regulated environment.
• Minimum of 2 years experience in the skillful preparation of technical files and design dossiers required
• Experience supporting EU MDR compliance implementation teams required
• Must be fluent in English, both verbal and written
Specialized Skills / Other Requirements
• Orientation for detailed work with emphasis on accuracy and completeness
• Effective written and oral communication skills
• Good organizational and planning skills; drives for results
• Effective analytical/problem solving skills
• Good interpersonal skills that include working well in a team environment and the ability to lead others.
• Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
• Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
• Working knowledge of international requirements and quality systems.
• Strong computer skills: Microsoft Office - PC, Word, Excel, PowerPoint, Outlook
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: 262-439-1894.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose.Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.
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