Cory Marsh Email & Phone Number

South Jordan, Utah, Us

Manage and oversite of Merit's global MDD & MDR CE Mark certification. Liaise with consultants, Notified Bodies, and National Competent Authorities in order to tailor the global MDD & MDR regulatory strategy as needed. Provide input to, and solicit feedback from, executive corporate management on strategic MDD & MDR objectives and progress. Provide guidance and direction to sites and divisions on global regulations, guidance documents, and international standard updates. Solicit input and direction from regional teams and disseminate to sites and divisions as needed.Manage the creation and maintenance of global regulatory procedures, systems, and processes needed to support all sites and divisions. Solicit feedback from sites and divisions and ensure alignment. Manage the creation and maintenance of training tools and resources needed to support Regulatory Affairs functions at all sites and divisions. Conduct training at all sites and divisions with Regulatory Affairs and various stakeholders.Represent Regulatory Affairs in site FDA, Notified Body CE Certificate, ISO, and MDSAP audits.Manage regulatory obligations for global corporate recalls and field actions. Manage global regulatory strategy and processes for the company’s convenience kit/procedure pack business. Manage regulatory specialists in their responsibilities and duties. Manage department budget of Regulatory Affairs Operations.

South Jordan, Utah, Us

Manage and oversite of Merit's global MDD & MDR CE Mark certification. Liaise with consultants, Notified Bodies, and National Competent Authorities in order to tailor the global MDD & MDR regulatory strategy as needed. Provide input to, and solicit feedback from, executive corporate management on strategic MDD & MDR objectives and progress. Provide guidance and direction to sites and divisions on global regulations, guidance documents, and international standard updates. Solicit input and direction from regional teams and disseminate to sites and divisions as needed.Manage the creation and maintenance of global regulatory procedures, systems, and processes needed to support all sites and divisions. Solicit feedback from sites and divisions and ensure alignment. Manage the creation and maintenance of training tools and resources needed to support Regulatory Affairs functions at all sites and divisions. Conduct training at all sites and divisions with Regulatory Affairs and various stakeholders.Represent Regulatory Affairs in site FDA, Notified Body CE Certificate, ISO, and MDSAP audits.Manage regulatory obligations for global corporate recalls and field actions. Manage global regulatory strategy and processes for the company’s convenience kit/procedure pack business. Manage regulatory specialists in their responsibilities and duties. Manage department budget of Regulatory Operations.

South Jordan, Utah, Us

Manage Merit's global EU MDR initiative. Set and execute Merit's global regulatory strategy for MDR compliance. Monitor and evaluate changes to MDR guidances, expectations, and interpretations and their impact on the global regulatory strategy. Liaise with consultants, Notified Bodies, and National Competent Authorities in order to tailor the global MDR regulatory strategy as needed. Provide input to, and solicit feedback from, senior management on strategic regulatory paths and progress.Manage and oversite of Merit's global MDD CE Mark certification. Liaise with consultants, Notified Bodies, and National Competent Authorities in order to tailor the global MDD regulatory strategy as needed. Provide input to, and solicit feedback from, senior management on strategic MDD regulatory strategy and progress. Manage regulatory obligations for global corporate recalls and field actions. Manage regulatory support of the OEM division by providing regulatory guidance to existing customer accounts and during new customer opportunities. Manage regulatory strategy and processes for the company’s convenience kit/procedure pack business. Manage RA Specialists in their responsibilities and duties.

South Jordan, Utah, Us

Manage the preparation and maintenance of U.S. (510(k)), EU (Technical Files), and Canada regulatory submissions and other pre-market filings to acquire the appropriate distribution clearance for new product designs or changes to existing product lines. Coordinate with international staff to maintain and acquire appropriate distribution clearance for other international markets. Manage regulatory strategy on design and development teams and manufacturing groups by providing guidance on domestic and international regulatory requirements of new product designs or changes to existing product lines. Manage regulatory obligations for global corporate recalls and field actions. Manage regulatory strategy for the OEM division by providing regulatory guidance on customized devices, kitting, and private labeling options. Manage regulatory strategy and processes for the company’s convenience kit/procedure pack business. Review product labeling and marketing collateral to ensure compliance with applicable clearances and regulations. Supervise and mentor other RA Specialists in their responsibilities and duties.

South Jordan, Utah, Us

Manage the preparation and maintenance of U.S. (510(k)), EU (Technical Files), and Canada regulatory submissions and other pre-market filings to acquire the appropriate distribution clearance for new product designs or changes to existing product lines. Coordinate with international staff to maintain and acquire appropriate distribution clearance for other international markets. Manage regulatory strategy on design and development teams and manufacturing groups by providing guidance on domestic and international regulatory requirements of new product designs or changes to existing product lines. Manage regulatory obligations for global corporate recalls and field actions. Manage regulatory strategy for the OEM division by providing regulatory guidance on customized devices, kitting, and private labeling options. Manage regulatory strategy and processes for the company’s convenience kit/procedure pack business. Review product labeling and marketing collateral to ensure compliance with applicable clearances and regulations. Supervise and mentor other RA Specialists in their responsibilities and duties.

South Jordan, Utah, Us

Manage the preparation and maintenance of both U.S. 510(k) and international (Technical Files, STED) regulatory submissions and other pre-market filings to acquire the appropriate distribution clearance. Represent Regulatory on design and development teams and provide guidance on domestic and international regulatory requirements of new product designs or changes to existing designs.

Warsaw, Indiana, Us

Performed quality system internal, supplier, and Alliance Partner audits to ensure compliance with 21 CFR 820, ISO 13485:2003, EU MDD, CMDR, PAL, ANVISA and general good manufacturing practices. Participated as a regulatory representative in external quality system audits conducted by notified bodies and outside consulting groups. Conducted product complaint investigations to lead and assist with recall actions. Reviewed and approved product and process validations. Reviewed and approved device history files, device master records, and design reviews throughout all phases of the design control process. Trained colleagues and personnel on the company’s quality system and control procedures, as well as external standards.Managed the preparation and maintenance of international (Technical Files, STED) regulatory submissions and other pre-market filings to acquire the appropriate distribution clearance. Represented Regulatory on design and development teams and provided guidance on domestic and international regulatory requirements of new product designs or changes to existing designs. Maintained an international standards list and identified new/revised standards and how they affected the quality system.

Researched/drafted memoranda regarding insurance law & conflict of law. Researched/analyzed state statutes & regulations governing insurance licensing requirements and transactions and drafted transactional documents to meet statutory compliance. Researched/analyzed: various issues under federal securities law; the application of federal and state privacy laws to company's business practices; ethical rules of attorney settlement agreements. Drafted letters regarding contract disputes with third party vendor. Participated in conference calls/negotiations with clients regarding potential business transactions. Attended CLE classes on behalf of company, & relayed information to general counsel.

Researched/drafted memoranda regarding securities, employment, contract, and trademark law. Drafted and edited contracts and NDA's. Monitored trademark registrations and drafted cease and desist letters. Updated privacy policy and terms of use for corporate web site.

Investigated and processed global contract violations by Nu Skin distributors. Assigned responsibility over Asian markets. Written and oral communication with distributors, attorneys, and government regulatory agencies regarding Nu Skin's policies and disciplinary process. Conducted training on company policies and procedures to domestic corporate departments and international branch offices.

J.D., Law

B.A., American Studies