• Lead and manage regulatory activities for new and existing products, including medical devices, IVD, LDT, AI/ML Devices and SaMDs. • Regulatory subject matter expert for IVD and LDT submissions for CD Diagnostics a Zimmer Biomet division.• Manage current regulatory affairs including regulatory submission authoring and publishing electronic submissions.• Manage regulatory affairs department, and provide guidance and direction to ensure the efficient and effective management of regulatory affairs activities.• Formulate regulatory strategies, and effectively communicate associated risks to project teams and RA management, while outlining proposals for mitigating project risks.• Establish Zimmer Biomet regulatory affairs policy and procedures, ensure compliance with the current regulatory procedures, and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect. • Keep all areas of Zimmer Biomet informed of domestic and international regulatory requirements and emerging issues that may affect the registration approval of products by efficiently handling and delegating multiple regulatory initiatives in accordance with business objectives and compliance requirements.• Assist in Zimmer Biomet regulatory matters related to (pre-) clinical studies, offering expertise and guidance to optimize the approval process and ensuring compliance with regulatory requirements when reviewing clinical study protocols.• Communicate with regulatory agencies and foster collaboration among program managers, technical staff, and cross-functional project teams to develop a comprehensive regulatory strategy for devices, resolve action items and deliverables as required.• Maintain strong working relationships with the FDA review team and engage in collaborative efforts with technical experts to ensure timely regulatory approvals and swiftly resolve any regulatory issues, promptly addressing agency questions.

• Subject matter expert & regulatory lead on new product (IVD and medical device) development.• Manage current regulatory affairs for various medical devices and IVD Devices, including smart mobile applications, those utilizing SaMD, SiMD, AI/ML technologies, and digital health.• Manage a team of Regulatory Affairs Specialists, and provide guidance and direction to ensure the efficient and effective management of regulatory affairs activities.• Manage and delegate multiple regulatory projects based on business needs and priorities to ensure timely completion and compliance.• Assist with regulatory submissions and approvals for medical devices and IVD devices utilizing advanced technologies.• Lead the preparation and submission of regulatory filings for complex medical device products, implement global registration strategies, including EU MDR/ IVDR implementation, and interpret medical device regulations.• Collaborate with program managers, technical staff, and cross-functional project teams to provide a regulatory strategy for devices and resolve action items and deliverables needed for (US) Pre-Sub strategy, submission, and market clearance.• Secure all US FDA market clearance and approval for new and existing medical devices through the preparation of regulatory submissions to the US FDA as the sole responsible party. • Work closely with the FDA review team and collaborate with technical experts to ensure timely regulatory approvals and resolve regulatory issues, responding to agency questions as necessary.

• Subject Matter Expert & core team lead on new product development.• Lead regulatory filings for moderately to highly complex submissions & global registration/ implementation strategies• Lead IVDR implementation.• Regulatory lead & SME for site transfers. • Interpret federal/state/international regulations related to BEC products, processes, and/or procedures, advise on the impact of regulations, & devise strategies for compliance.• Support BEC business units (Diagnostics & Life Sciences) to develop, lead, & integrate the company's regulatory strategies and programs.• Collaborate with program managers, technical staff and, cross-functional project teams to provide a regulatory strategy for devices and resolve action items and deliverables needed for (US) Pre-Sub strategy, submission, market clearance.• Establish the need for and prepare regulatory submissions, negotiate the resolution of agency questions, & secure market clearance and/or approval for new products, author SW section of 510(k), and/or design changes to existing products.• Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market the company's products in that geography.• Lead & Train RA members on Design Change reviews, RRFs, promotional reviews, labeling, 510k, guidance documents, and RA strategy.• Respond to regulatory agency inquiries, Interact with FDA, Lead presenter in the interactive meeting.• Apply and/or write complete the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.• Lead legalization, Apostille, and notarization process.• Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments & requirements.• Lead & train RA members on global registrations.• Other duties as required at the Staff level (FURLS, Member of MAPSS Council, etc.).

• Prepare EUA's, WHO pre-qualification, pre-market submissions & registrations of Medical Devices (IVD's) for submission to regulatory agencies.• Collaborate with the maintenance of regulatory submissions & regulatory files related to 510(k), IDE /IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, & Technical Files for a diverse range of medical devices as required by US FDA, MDD/MDR, IVD/IVDR, HC, CMDCAS, TGA, ANVISA, MHLW & PMDA, ASEAN & by rest of the world regulatory agencies.• Collaborate with Cross-functional teams to ensure high-quality regulatory filings, negotiate the resolution of agency questions, & secure market clearance &/or approval for new products &/or changes to existing products.• Develop global regulatory strategies to ensure rapid & timely approval of devices & continued regulatory support of marketed devices & other products. Interact with regulatory agency personnel to expedite approval of pending applications & to resolve regulatory matters.• Assist in establishment registrations, product registrations (In Vitro Diagnostics), routine regulatory documents compilation, development, submission, and maintenance of worldwide regulatory filings. Apply for FDA (CFG & COE) Export Certificates, Certificates of Free Sales, & write Declaration of Conformity. Manage the legalization, Apostille, & notarization process as required.• Collaborate with regulatory & compliance issues by providing independent regulatory guidance & support to product development teams for strategic planning, design & development, & post-market surveillance & compliance activities, and successful project delivery.• Review & approve proposed labeling, packaging, advertising & promotional materials after evaluating conformance to regulations.• Assist with regulatory bodies and MDSAP audits, document control, complaint handling, & CAPAs to ensure appropriate regulatory assessments & requirements are met.

• Consult clients globally in Medical Devices, IVD sectors in activities concerned with complex submissions & approvals of products to govt. regulatory agencies.• Assist in the preparation & maintenance of regulatory submissions & files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, & Technical Files for a diverse range of medical devices as required by US FDA, MDD/MDR, HC, CMDCAS, TGA, ANVISA, MHLW & PMDA, ASEAN & by rest of the world regulatory agencies.• Consult with management personnel to establish & prepare appropriate regulatory filings, negotiate the resolution of agency questions, & secure market clearance &/or approval for new products &/or changes to existing products.• Develop world-wide regulatory strategies to ensure rapid & timely approval of devices & continued regulatory support of marketed devices & other products. Interact with regulatory agency personnel in order to expedite approval of pending application & to resolve regulatory matters.• Assist clients in establishment registrations (21 CFR 807), product registrations, routine regulatory documents compilation, development, submission, and maintenance of worldwide regulatory filings. Apply or write FDA Certificates to Government & Export Certificates, Certificates of Free Sales, & Declaration of Conformity. Manage legalization, Apostille, & notarization process as required.• Provide guidance to clients regarding regulatory & compliance issues by providing independent regulatory guidance & support to product development teams for strategic planning, design & development, & post-market surveillance & compliance activities.• Review & approve proposed labeling, packaging, advertising & promotional materials after evaluating conformance to regulations.• Assist with audits, document control, complaint handling, & CAPAs to ensure appropriate regulatory assessments & requirements are met.

• Consulting clients in Dietary Supplement and Pharmaceutical industries for product Designs and Regulatory Compliance.• Providing research and advice to clients on compliance with federal laws, FDA/USDA regulatory agency guidelines, FTC regulations, DSHEA Compliance, cGMP Readiness and EU Food Supplements Directive (FSD) as per EFSA.• Researching government initiatives related to labeling and packaging for Clients as required.• Helping Clients with proofreading of pharmaceutical package inserts and labels ensuring accuracy and consistency as per industry and government guidelines.• Ensure labeling content, and product documentation is developed in accordance with FDA/ DSHEA and International regulatory requirements.• Coordinate with the Labeling/Promotional group for the development of product labels and support of promotional materials.• Prepare and review Dietary Supplement registration dossiers for regulatory compliance in common technical document (CTD) or as per country specific requirement for international countries. • Assist in preparing submissions for US NDIN submission and EU novel foods submission.• Write and review the Marketing Authorization Application (MAA) on Herbal Medicines.• Assist in preparation and edition of Summary of Product Characteristics (SPC), Standard Operating Procedures (SOP), Standing Testing Procedures (STP) and Certificate of Analysis (Analytical Report). •Coordinate the preparation of Prior notice filing, ingredient and product reviews, Structure/ function claims, DS MMR and BPR reviews, DWPE petition submission.• Liaise with pharmaceutical Regulatory Affairs personnel outside the US for international submissions and registrations as required by the clients.• Interact with appropriate stakeholders including but not limited to customers, medical professionals, field staff, and affiliates to obtain information pertinent regulatory documentation.• Assist in mock FDA inspections and international regulatory agencies audits

• Assist clients with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs)• Enter data as presented into the Complaint Management System and initiate Product Quality Complaint Investigation processing for internal and /or external manufactured products.• Help investigate complaints to determine root cause, identify resolution, confirm correction, and respond to complainants as required.• Create and support Non-Conforming Material Report (NCMR) and determine its escalation to a SCAR (Supplier Corrective Action Request).• Assist and participate in CAPA investigations and enter all the information in the Compliance Management System.• Assist in complaints regulatory reporting process (timely submissions, closure, health authority requests, etc.).• Develop and execute a strategy for discovering and securing new business opportunities either locally, regionally, or nationally.• Develop negotiation strategies by evaluating risks and potentials.• Foster beneficial relationships with business partners, potential clients, and business contacts to attract new business and enhancing organization reputation.• Represent the company at trade organizations, on committees, and during board meetings, when necessary.• Assist the company with licensing and regulatory documentation as required by the state and federal authorities.• Develop and execute a strategy for discovering and securing new business opportunities either locally, regionally, or nationally.• Develop negotiation strategies by evaluating risks and potentials.• Foster beneficial relationships with business partners, potential clients, and business contacts in order to attract new business and enhancing organization reputation.•Represent the company at trade organizations, on committees, and during board meetings, when necessary.• Assist the company with licensing and regulatory documentation as required by the state and federal authorities.

· Supervised, managed, coached and developed pharmacy team in providing pharmacy services.· Strategized and planned pharmacy business operations.· Analyzed and created business policies and procedures.· Created and managed compounding department per FDA Section 503A.

· Managed, coached and developed providing retail pharmacy teams for pharmacy services.· Designed and implemented, policies and procedures for pharmacy department operations.· Mentored the teams to achieve top performance metrics year after year.· Supervised retail pharmacy operations for multiple units.