Regulatory Affairs Manager

2 weeks ago

Arden Hills, United States Knewin Full time

Recruiter:

Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is considered part of the RM RA Leadership team. This role will manage and provide leadership to 3-4 regulatory submission specialists. The Manager I for Cardiac Rhythm Management (CRM) would report to the CRM Director. The role is Hybrid, with office location in Arden Hills, MN. This role will be singularly focused on providing valued regulatory management support for high priority activity within the Core CRM Sustaining Program. This role will be expected to represent the Regulatory Affairs function during multiple cross-functional project meetings and fulfill a people management role with 3-4 Regulatory Affairs submission specialists as direct reports. This device system portfolio includes class III and class II devices, along with related system accessories, for US, EU, APAC, LATAM, CA, AUS.NZ and other geographies. This role will also be responsible for representing Core CRM Regulatory interests within cross functional meetings held by Sustaining PMOs as assigned by the regulatory Director. Key Responsibilities: Oversite management of Core CRM Regulatory Affairs Sustaining Program activities, with an emphasis on Leads and Lead accessories product portfolio. Manage a 3-4 person submissions team within a matrixed organization. Lead the CRM transition away from PFAS materials to more eco friendly alternatives. Be responsible for required device and accessory product change submissions - FDA and EU MDR, EU Cert Renewals, e-Labeling, along with required product release approvals (PRA). Participate with fellow CRM Managers on Change Notice (CN) meetings and Sustaining Project assignments for RA Specialists on their respective teams. Encourages and facilitates professional development of direct reports. Hires, evaluates, and trains direct reports. Coordinates with RM Director and Management in establishing project priorities, allocating resources and workload. Develops and utilizes relationships, tools, processes, and other resources to assist in solving problems and gain efficiencies through Lead and Lead Accessories Sustaining Program Portfolio initiatives. Collaborate with CRM Reg leadership to develop efficiency tools/processes to better manage functional activities related to Lead Accessories Sustaining Program portfolios. Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Required Qualifications: Minimum of a bachelor’s degree. Minimum of 4 years’ experience working under a quality system or a related discipline (e.g., Regulatory Affairs, Project Management, Quality Systems, R&D, Post Market, Operation Management) Prior experience leading and/or managing others. Excellent written and oral communication Excellent research and analytical skills Ability to manage multiple projects simultaneously. Proven leadership, collaboration and influencing skills. Demonstrated ability to effectively collaborate with cross-functional partners/teams. Track record of working independently with minimal supervision. Demonstrated success as the lead on cross-functional teams. Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint). Preferred Qualifications: Experience with working within R&D project core team as a function lead. Working knowledge of FDA, EU and/or international medical device regulations or experience in similar regulated industry/environments. Experience with audits from government bodies (e.g., FDA, MDSAP, ISO 13485), or related activities. Ability to read and interpret regulations and standards. General understanding of product development process, design controls and quality system regulations. Requisition ID: 577641

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