Chris Mckee Email & Phone Number

Palm Beach Gardens, Fl, Us

Palm Beach Gardens, Fl, Us

• Oversee all Quality, Regulatory Affairs and Regulatory Compliance operations and personnel for the organization including QMS management, supplier management, product inspection/compliance, post-market activities, continuous improvement, audits and global regulatory submissions• Represent the QA/RA organization as a member of the Executive Leadership Team to drive QA/RA strategies and policies companywide • Oversee department budgets and company QA/RA initiatives• Represent the organization with regulatory agencies including critical certification audits• Develop and implement QA/RA improvement and compliance initiatives to ensure safe and compliant products and processes• Develop personnel in development of strategies and interpretations of applicable Quality and Regulatory regulations, laws and practices

We offer consulting services in the areas of Regulatory Affairs, Quality & Regulatory Compliance for medical device companies. This includes:- Regulatory Affairs: Regulatory strategy development; Regulatory submissions (FDA, CE Marking, Health Canada, TGA, other international markets); assessing and implementing Regulatory requirements in design controls and for design changes.- Quality & Regulatory Compliance: Quality Management System development, implementation and improvements; Expertise in areas of CAPA, Audit Management, Post-market surveillance, Change Control, Document Control, Training, Corrections & Removals

Palm Beach Gardens, Fl, Us

Palm Beach Gardens, Fl, Us

Responsible for all global regulatory affairs and compliance operations at ZimVie Dental (Biomet 3i and Zimmer Dental) including global registrations, quality system management, internal and external audits, corrections and removals, management representative and regulatory strategies. Also responsible for the ZimVie Spine international RA/QA teams in EMEA, APAC and LATAM.

Palm Beach Gardens, Fl, Us

Responsible for all global regulatory affairs and compliance operations at Zimmer Biomet Dental (Biomet 3i and Zimmer Dental) including global registrations, quality system management, internal and external audits, corrections and removals, management representative and regulatory strategies.

Palm Beach Gardens, Fl, Us

Responsible for Quality Management System compliance and implementation, the CAPA system, all internal and external audits, Corrections and Removals, Document Control, Training and Supplier Quality for the Dental business with teams across the four sites. Currently serving as the site Management Representative and Person Responsible for Regulatory Compliance for two of the Dental sites.Lead MDSAP certification for Dental sites. Actively working with Notified Bodies for certificate transfers and updates. Responsible for EU MDR implementation and transition for the two Dental businesses.

Palm Beach Gardens, Fl, Us

I managed the Regulatory Affairs department which consisted of six direct reports. My group was responsible for global Regulatory product registrations and compliance with associated regulations. My team also worked on design control teams for new products.

Minneapolis, Mn, Us

I served as the Regulatory team lead for the company's largest new product line, the CD HORIZON SOLERA Spinal System consisting of over 7500 part numbers. My responsibilities included developing and executing global regulatory plans and ensuring design controls are followed and completed. I was responsible for the successful clearance of sixteen 510(k) submissions, CE marking and registrations in other global markets including Canada, Japan and Australia. I also served as the core Regulatory team lead for an ongoing IDE responsible for IDE changes and submissions such as annual reports and supplements.Coordinated and led a compliance project and project team in response to a warning letter issued by FDA, which involved researching and updating two years’ worth of product documentation, changes and activities.Assisted in detailed project scheduling/planning and developing global business plans including global regulatory strategies and plans for new product and platform launches.Represented Regulatory Affairs on design control teams for multiple product lines to ensure appropriate compliance with ISO 13485, ISO 14971 and 21 CFR 820.Provided guidance to product development regarding necessary design verification and design validation activities (including mechanical testing) to support market clearances/approvals.Reviewed promotional and marketing material to ensure labeling compliance and adequate substantiation for claims.Mentored and trained new and junior associates on company processes/procedures and regulatory strategies.Published Regulatory submissions using various publishing software programs.Reviewed and assessed engineering change orders to determine the for potential impacts to domestic and international market approvals/clearances.