Regulatory Product Specialist, MDR

Position Summary

The Regulatory Affairs (RA) Specialist for European Union Medical Device Regulation (MDR) will be responsible for supporting execution to Interventional’s MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule. The MDR RA Specialist will partner with the other Interventional cross functional teams to provide regulatory feedback on all MDR project/design deliverables and to author/lead corresponding MDR submissions (including remediation activities identified during MDR submission reviews).

Principal Responsibilities

•    Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements. This will require a review of all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity and clinical data.
•    Collaborate with Interventional MDR Project Manager (PM) to determine an implementation plan to complete updates to technical documentation. Support implementation with cross-functional execution of necessary RA deliverables.
•    Author EU MDR Technical Documentation Summaries (TDS) for submission to notified body per MDR compliance plan schedule.
•    Work with MDR PM, Interventional RA staff and all applicable MDR program work stream leads to ensure technical documentation update timelines are aligned.
•    Support the collection and provision of data required to submit to EUDAMED, as deemed necessary by MDR.
•    Provide input into other MDR workstreams, such as labeling, as required.
•    Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific Anesthesia RA team member and/or design teams.
•    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.
•    Support, as required, new product development teams to ensure collection of appropriate data for MDR regulatory submissions and compliance.
•    Identify use of appropriate international standards for carrying out remediation activities.
•    Monitor MDR government agency laws and regulations through websites, publications, and MDR team meetings, and relay updates to Interventional RA team members.
•    Determine issues which may create regulatory obstacles, questions/issues; investigate and propose solutions; escalate to MDR PM and Business Unit (BU) Management, as necessary.
•    Provide guidance to Interventional RA staff as related to the MDR project.
•    Provide other departmental support as requested by immediate supervisor.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    Minimum of a bachelor's degree, preferably in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.
•    Minimum of 2 to 4 years’ experience working in medical device regulatory affairs (or equivalent).
•    Experienced in the skillful preparation of technical files and design dossiers
 

Specialized Skills / Other Requirements

•    Orientation for detailed work with emphasis on accuracy and completeness.
•    Effective written and oral communication skills; ability to succinctly and accurately communicate to various levels of management.
•    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.
•    Computer Literate: Microsoft Office (PC, Word, Excel, PowerPoint) and Adobe Professional

TRAVEL REQUIRED:  5%
 

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