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Director, Regulatory Affairs, Clinical Studies and Quality Systems

Job Title:
Link to apply:
Job city: Minneapolis

Type of job: Full Time (Salaried)

Job summary:

Director, Regulatory Affairs, Clinical Studies and Quality Systems
Location: US-MN, Minneapolis (Headquarters)
Department: Urology Care
Job Function Summary:
This leadership position represents the Regulatory, Clinical, and Quality Systems (RCQ) departments on the Surgical Urology executive management team.  The Director of RCQ brings best practices to the group and provides strategic direction by aligning the RCQ functions with the business strategy and the other functional areas.  The Director of RCQ works closely with our global organization to ensure appropriate and timely expansion of the Surgical Urology business. A hands-on approach is required to develop a cohesive team, foster a culture of collaboration, deliver timely results and elevate business performance to the next level. 
Major Areas of Accountability:
?Direct the budget, staff, resource allocation and responsibilities for Regulatory Affairs, Clinical Studies and Quality Systems (RCQ). This includes setting, monitoring and maintaining department goals and individual objectives for the team to assure regulatory compliance is maintained
?Direct work assignments with Regulatory Affairs to assure efficient and effective utilization to complete regulatory strategies and regulatory submissions to support the business needs.  Submissions include IDEs, 510(k)s, PMAs, Canadian MDL, Canadian DIN, Canadian cosmetic listing, CE technical files, TGA applications
?Ensure appropriate Regulatory, Clinical and Quality strategies leading to timely and successful projects and programs including, but not limited to:  regulatory submissions, postmarked approvals, ISO certifications, audits, CAPA and complaint handling systems, Quality Management Systems, etc.
?Active participation in Surgical Urology Management Team (SUMT) and appropriate management meetings decision making with active monitoring of conformance to the regulatory requirements to ensure that products meet the intended use and user needs with sufficient documentation to support global regulatory clearance/approval
?Direct the internal audit program, monitor compliance to schedules for resulting action items ? regularly review and maintain corporate/ local process/ procedures/ instructions to assure ongoing compliance to regulatory, global and local standards
?Act as Official Correspondent towards FDA at Coloplast Group level, facilitating and supporting timely and adequate dialogue with FDA
?Direct activities around external audits by FDA, ISO notified bodies, contract auditing agencies, customers, internal auditors or any other appropriate agencies
?Support product registration at group level for products to be marketed in the US and Canada
?Provide oversight for the development and maintenance of quality programs, processes and procedures that ensure compliance with policies and that performance and quality of services conform to established standards and agency guidelines
?Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance
?Identify, effectively implement, improve and maintain Regulatory, Clinical and Quality Systems processes
?Maintain current knowledge of regulations and requirements for relevant product categories in relevant geographies and communicate those within the company and to external partners
?Direct the maintenance activities related to design changes, site registration, product listings and assure the documentation is kept current in the design history files with appropriate regulatory applications as needed
?Direct the staff training program to ensure understanding of requirements to support compliance with local/ global procedures

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