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Click here or scroll down to respond to this candidateCandidate's Name
Ormond Beach, FL Watertown, MA RemoteEMAIL AVAILABLE PHONE NUMBER AVAILABLE LinkedInRegulatory Affairs Compliance professional with Street Address + years of FDA regulatory expertise, specializing in medical devices and pharmaceuticals. Proven record of accomplishment in developing comprehensive compliance programs, including medical device assessments, risk mitigations, and product launches. Proficient with cross-functional collaboration, process improvement, program/project management, regulatory strategy, third party compliance, marketing, and aligning organizational goals with regulatory global compliance policies.Professional ExperienceSenior Healthcare Regulatory Compliance Manager 2021 PresentMicrosoft Corporation (Formerly Nuance Communications) (Remote)Provide expert regulatory guidance supporting legal department for medical devices, conducting internal assessments for both U.S. and global markets. Offer strategic advice on SaMD regulations, software supply chains, marketing, labeling, QMS, and ISO 13485 standards. Steer complex legal frameworks including CMS, Stark Law, FWA, and Anti-Kickback regulations. Oversee compliance with NHS DCB0129 clinical risk management reporting requirements and advise on Rx medical device distribution licensing.Advise on U.S. and international regulations for medical devices, third party risk vetting, software supply chain, compliance due diligence protocol, and registration requirements as FDA SME.Present to stakeholders, articulating the regulatory impacts and legal requirements for medical devices.Facilitated international regulatory affairs guidance pertaining to medical device regulations, white papers for the EU market.Train product managers on assessment tools, AI compliance requirements, collaborate and advise on product design controls and risk mitigation.Developed a program charter detailing the medical device program's scope, and objectives.Established the medical device program at Nuance, including policy and procedure creation, assessment tools, and implemented compliance controls to meet regulatory requirements.Senior Regulatory Analyst 2019 2021AbleTo, Inc., New York, NY (Remote)Tracked and analyzed federal and state health regulatory guidelines, assessing the impact of evolving regulations. Provided regulatory insights to ensure compliant solutions and developed policies and procedures to address regulatory changes effectively.Developed and implemented regulatory compliance due diligence reporting tools while enhancing reporting accuracy streamlining compliance processes.Advised on Federal and State license submission requirements, offering strategic regulatory guidance that improved submission efficiency and reduced approval times.Fostered NCQA and URAC accreditation regulatory guidance to clinical teams, achieving a 100% success rate in meeting accreditation standards and improving overall compliance.Revitalized regulatory compliance dashboard, conducted competitive intelligence, and performed risk assessments, optimizing compliance tracking, and reducing risk exposure.Senior Regulatory Pharmacy Compliance Manager 2016 2019Premier, Inc. Charlotte, NC (Remote)Oversaw the management of CMS, Medicaid, FWA, and FDA registrations, as well as credentialing and accreditations for URAC, ACHC, and NCPDP. Directed pharmacy licensure and conducted supply chain analytics to optimize Rx distribution to patients, hospitals, and wholesalers, ensuring compliance across all regulatory and operational aspects.Designed and implemented a Pharmacy Management database license management portal, which streamlined license tracking and compliance.Established an electronic prescription drug monitoring program across all 50 states which enhanced prescription oversight in accordance with PDMP regulatory requirements.Oversaw 340B inventory with a focus on resolving discrepancies, ensuring consistent Medicaid and Medicare compliance, and reducing audit findings.Encouraged mergers and acquisitions integration by addressing inherited disciplinary issues and performing thorough due diligence, which contributed to a smoother transition and maintained business continuity.Regulatory Compliance Contractor 2012 2016Smith & Nephew, T2 Biosystems, MassHealth Boston, MASpearheaded procurement, quality engineering, and compliance for global operations, conducting on-site audits to ensure adherence to standards. Identified and reported fraudulent behavior among providers and facilities, enhancing operational integrity and safeguarding against compliance risks.Improved clinical trial agreements by reviewing intellectual property terms and implementing a tracking protocol, which increased agreement accuracy and streamlined trial management processes.Served as a compliance investigator and program auditor for Commonwealth of Massachusetts Medicaid and Medicare programs while addressing compliance issues that enhanced audit outcomes.Reported incidences of healthcare fraud to the Massachusetts Attorney General's Office, contributing to successful investigations and recovering over $2 million in fraudulent claims.Senior Regulatory Affairs Manager 2000 2011Fresenius Medical Care North America Waltham, MAActed as the direct liaison between the Medical/Regulatory Affairs department and state pharmacy boards and federal regulatory authorities, overseeing all pharmacy and Rx wholesale licensing.Contributed to successful NDA, ANDA, and 510(k) submissions to the FDA for Class II & III drugs and devices, facilitating timely market entry.Developed and implemented Standard Operating Procedures (SOPs) and Corrective and Preventive Actions (CAPAs) in response to audit findings, leading to a reduction in audit non-conformities.Initiated, designed, and implemented an Rx Drug Pedigree system and license tracking database, enhancing traceability, and reducing license tracking errors.Managed a team of 10 to 12 regulatory affairs professionals, fostering a collaborative environment that improved team performance and regulatory compliance.Education & CertificationsMCC - Associate of Science in Law/Microbiology MCC - Paralegal CertificationHIMSS - Healthcare Information Management Systems HIPAA CertificationNEU - cGMP Regulatory Affairs CertificationWGU - Bachelor of Science in Healthcare ManagementRAPS - Regulatory Affairs Certification (drugs) RAPS - Regulatory Affairs Certification (devices) (In-View) |
