Head Of Regulatory Affairs Interventional Urology North America Roseville

Company: JobLeads
Location: Roseville
Posted on: September 14, 2020

Job Description:

Head Of Regulatory Affairs Interventional Urology North America Roseville - JobLeadsCareer Opportunities: Head of Regulatory Affairs (Interventional Urology) - North America (48040)Head of Regulatory Affairs (Interventional Urology) - North AmericaColoplast has an exciting opportunity for a Head of Regulatory Affairs to join our North American Interventional Urology team.This is a senior leadership position. This position directs the regulatory affairs functions to secure/maintain product approvals in assigned geographies and to assure compliance with applicable regulations and corporate requirements. You will be the US Agent and Official Correspondent to the FDA and Health Canada for Coloplast A/S and all associated locations.Major Areas of Accountability--- Support the Director of Global Regulatory Affairs in all RA initiatives to ensure consistent practices within the Team.--- Manage the budget, staff, and responsibilities for regulatory affairs including setting, monitoring and maintaining department goals and individual objectives to assure regulatory compliance is maintained. Serve as Official Correspondent to FDA and Health Canada. Serve as US Agent for Coloplast A/S and other Coloplast manufacturing sites. Authorized to CE-mark Intervential Urology products and interact with notified bodies.--- Manage work assignments for the Regulatory Affairs staff to assure efficient and effective utilization to complete regulatory submissions and maintenance activities to support the business needs. As part of the Regulatory Affairs Group, perform hands on work on a variety of projects as needed.--- Oversee Regulatory Affairs support for the organization through active participation on project teams with development of regulatory deliverables per the project plans and active monitoring of conformance to the design assurance requirements to ensure they meet the intended use and user needs with sufficient documentation to support global regulatory clearance/approval.--- Manage the maintenance activities related to design changes and assure that the documentation is kept current in the design history files with appropriate regulatory applications if needed--- Manage the RA staff training program for assuring understanding of requirements to support compliance with procedures/instructions and applicable regulations.--- Regularly review and maintain as needed corporate and local procedures/instructions to assure ongoing compliance and appropriateness for local needs--- Manage post-market surveillance, adverse event reporting, health hazard evaluation and recall--- Manage the budget, staff, and responsibilities for regulatory affairs and activities including setting, monitoring and maintaining department goals and individual objectives to foster improved effectiveness and efficiency of the department.--- Maintain current knowledge of regulations and requirements for relevant product categories in relevant geographies and communicate those within the company and to external partners. Support Coloplast at meetings with FDA and primary contact for audits with Health Canada.--- Direct preparation of regulatory strategies and submission preparation including IDEs, PMAs, 510(k)s, Canadian medical device licenses, Canadian drug identification number applications, Canadian natural health products, and CE dossiers for EU on Interventional Urology products. Assure that appropriate maintenance of registrations occurs including renewals, device and drug listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.--- Participate and support decision maker for recalls in the US of Interventional Urology devices. Provide resources to manage execution and communication with authorities for all recalls in the US or Canada.--- Direct design assurance support for the US R&D organization.--- Maintain cross-functional partnerships with the QA, Clinical, R&D and Global Operations to ensure alignment with overall business strategies and to ensure that regulatory requirements are met for medical devices--- RA support for Implant Device registrations in emerging markets.--- Co-host external audits by FDA, ISO notified body quality audits, customers or other appropriate agencies. Assist in developing and tracking appropriate corrective action.--- Conforms with Coloplast Code of Conduct and all local Compliance Standards--- (--- Conforms with Coloplast Q/EHS Policy--- ( policy.pdf)--- Other duties as assignedBasic Qualifications--- 8+ years related experience in medical device industry working with class II and class III medical devices--- 3+ years successful Regulatory Affairs management experience preferred--- Experience and demonstrated application of FDA and ISO quality system requirements.--- Experience and demonstrated application of FDA, Health Canada & EU Regulatory submissions--- MS or BA/ BS degree with equivalent experience & education preferred--- Live in the Minneapolis/ St. Paul, MN Metropolitan area--- Ability to travel including international up to 30%Required Knowledge, Skills, and Abilities--- Be solution o

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