Christina Nichols
Associate Director of Regulatory Affairs at Organogenesis- Claim this Profile
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Topline Score
Bio
Cynthia Ryk, M.Ed
Christina's enthusiasm for learning processes and more about herself to succeed are unparalled. She has great discipline, creativity, and drive to accomplish whatever she sets out to do. She has a strong work ethic that will serve any company very well.
Jamie Smelser Gothro
Christina is a detail-oriented in-vivo research associate who provided timely care to her animal subjects and worked closely with research staff to provide study related procedures and surgeries. Christina is extemely organized and was instrumental in implementing many systems and processes to enhance our operations. She is exceptional at creating presentations and training modules. She is dedicated to her work, and a pleasure to work with. Christina would be an asset to any organization.
Cynthia Ryk, M.Ed
Christina's enthusiasm for learning processes and more about herself to succeed are unparalled. She has great discipline, creativity, and drive to accomplish whatever she sets out to do. She has a strong work ethic that will serve any company very well.
Jamie Smelser Gothro
Christina is a detail-oriented in-vivo research associate who provided timely care to her animal subjects and worked closely with research staff to provide study related procedures and surgeries. Christina is extemely organized and was instrumental in implementing many systems and processes to enhance our operations. She is exceptional at creating presentations and training modules. She is dedicated to her work, and a pleasure to work with. Christina would be an asset to any organization.
Cynthia Ryk, M.Ed
Christina's enthusiasm for learning processes and more about herself to succeed are unparalled. She has great discipline, creativity, and drive to accomplish whatever she sets out to do. She has a strong work ethic that will serve any company very well.
Jamie Smelser Gothro
Christina is a detail-oriented in-vivo research associate who provided timely care to her animal subjects and worked closely with research staff to provide study related procedures and surgeries. Christina is extemely organized and was instrumental in implementing many systems and processes to enhance our operations. She is exceptional at creating presentations and training modules. She is dedicated to her work, and a pleasure to work with. Christina would be an asset to any organization.
Cynthia Ryk, M.Ed
Christina's enthusiasm for learning processes and more about herself to succeed are unparalled. She has great discipline, creativity, and drive to accomplish whatever she sets out to do. She has a strong work ethic that will serve any company very well.
Jamie Smelser Gothro
Christina is a detail-oriented in-vivo research associate who provided timely care to her animal subjects and worked closely with research staff to provide study related procedures and surgeries. Christina is extemely organized and was instrumental in implementing many systems and processes to enhance our operations. She is exceptional at creating presentations and training modules. She is dedicated to her work, and a pleasure to work with. Christina would be an asset to any organization.
Credentials
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Advanced Certificate in Regulatory Affairs
San Diego State UniversityMay, 2022- Nov, 2024 -
Regulatory Affairs for the Biomedical Industry Certificate
UC San Diego ExtensionJun, 2013- Nov, 2024 -
RAC-DEVICES
Regulatory Affairs Certification ProgramDec, 2019- Nov, 2024
Experience
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Organogenesis
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Biotechnology Research
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700 & Above Employee
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Associate Director of Regulatory Affairs
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Feb 2023 - Present
Lead multi-site regulatory programs for cell and tissue-based products (361 HCT/Ps, medical devices (PMA, 510(k)), and biologics (IND). Planned and executed regulatory strategies for global regulatory pathways, preparation of submissions and reports to FDA and other regulatory agencies, as well as interfaced with regulatory agencies to facilitate regulatory approvals/clearances and maintain compliance.
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Regulatory Affairs Manager
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Sep 2021 - Feb 2023
Manages the regulatory aspects of multiple programs associated will cell-based combination products, 361 HCTPs, medical devices (PMA, 510(k)). Planning and executing regulatory strategies for regulatory pathways, preparation of submissions and reports to FDA and other regulatory agencies, as well as interfacing with these regulatory agencies to facilitate approvals and maintain compliance.
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Program Manager, Regulatory Affairs
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Aug 2017 - Sep 2021
Regulatory lead for Organogenesis’s La Jolla site primarily responsible for managing the regulatory aspects of multiple programs associated with cell-based PMA approved medical devices and 361 HCT/Ps. Planning and executing regulatory strategies for regulatory pathways, preparation of submissions and reports to FDA and other regulatory agencies, as well as interfacing with these regulatory agencies to facilitate regulatory approvals and maintain compliance.
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Lorem Cytori USA, Inc
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Associate III
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Apr 2014 - Feb 2015
Regulatory Affairs Associate responsible for activities related to domestic FDA and international product applications, product/ establishment license preparation and maintenance, import/export medical device registration. Performing ECO’s for product Labeling (IFU, device label, brochures, marketing materials), device drawings, testing protocols and reports as well as updating SOP/WI’s, supporting the development of the technical file, and device master record for CE Marking for compliance to MDD and FDA regulations. Show less
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Regulatory Associate II
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Mar 2011 - Apr 2014
Regulatory Affairs Associate responsible for activities related to domestic FDA and international product applications, product/ establishment license preparation and maintenance, import/export medical device registration. Performing ECO’s for product Labeling (IFU, device label, brochures, marketing materials), device drawings, testing protocols and reports as well as updating SOP/WI’s, supporting the development of the technical file, and device master record for CE Marking for compliance to MDD and FDA regulations.• Regulatory representative for non-Cytori manufactured products, Puregraft product line as well as New Product Development (NPD) participating in cross functional core/development team meetings to provide regulatory guidance and support for effective product marketing for both domestic and international clearance; ensure operational compliance with regulations.• Implemented a product label standardization guideline, facilitated cross functional meetings and coordinated ECO’s for rolling changes for all corporate labeling. • Performed 510(k), Technical File and Clinical Trial file compilation, submission and file maintenance.• Provided clinical literature evaluation review/updates as well as writing clinical study summaries. • Written correspondence and oral communication and negotiations with internal and external parties.• Experience with ISO, MDD and CFR adherence as well as document submissions for FDA Class I and II devices as well as international applications and registrations for Class I, IIa and IIb medical devices. Show less
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DJO
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Regulatory Affairs Specialist II
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Dec 2009 - Feb 2011
Regulatory Affairs Specialist responsible for activities related to Domestic FDA and International product registration, listing, and import/export medical device registration. Performing ECO’s for product labeling, MDR Assessment, complaint investigation for product safety, MedWatch reporting as well as participating in New Product Development (NPD) Projects while supporting the development of technical files, and device master record for CE Marking for compliance to MDD, CMDR and FDA. • Lead for the Global Product Registration (GPR) database, creating SOPs, performing document creation, coordination, compilation, and submission for international registration of a newly acquired product line through a company merger (Chattanooga) as well as the entire product families owned by DJO. • Experience with ISO, CFR adherence as well as document submissions for FDA and international distributors of medical devices. Show less
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REVA Medical, LLC.
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United States
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Medical Device
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1 - 100 Employee
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Pre-Clinical Data Administrator
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Feb 2009 - Nov 2009
Managed, verified, and accounted for large volumes of data for preclinical studies. Modified quality assurance procedures performed internal audits and managed the archive of preclinical projects in document control while working closely with Quality Department. • Experience with ISO, CFR adherence as well as NIH grant submissions for medical devices. • Developed aspects of the preclinical department website, for tracking and managing study related projects. • Performed microdissections as well as SEM sample preparation; utilizing digital images to capture data as well as written records for study reports. Utilize Aperio software for tissue diagnostics. Show less
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Amylin Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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400 - 500 Employee
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In-Vivo Research Associate II
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Oct 2005 - Nov 2008
Provided surgical and technical procedure support for in-vivo pharmacology department. Provided quality assurance for protocol compliance through daily health observations and post operative care monitoring. Functioned as the training coordinator for all research personnel focusing on training and verifying competency for all hands on skills for in-vivo procedures. Surgical and Procedural Experience: Subcutaneous osmotic pump implants, vessel canulations, venous access ports, telemetry, IT canulation, sterile procedures, injections-IM/SC/IP/IV, blood collections-Retro orbital/ IV/ Cardiac/ Submandibular /Jugular, sample processing, microchip, Culex/Piximus, terminations, autoclave, hematocrit. • Monitored animal protocol adherence and post-operative compliance through a protocol post approval monitoring system which included daily observations and random audits. • Organized and maintained the Comparative Medicine Biosafety (Rodent Sentinel) Monitoring Program. Show less
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Field Service TechnicianV
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Dec 2004 - May 2005
Implemented a disease surveillance and monitoring system by contributing to field service sample collection and data analysis along with case coordination and review with respective veterinarians for herd health.• Provided customer service to clients regarding individual cases and testing results.• Gathered and monitored data from herd health programs for case review. • Maintained continued support and assistance for veterinarians and professionals within the field and veterinary services. • Participated in field investigations/visits, sample collection, organization, as well as data analysis and data entry for the laboratory management system (UVIS). Show less
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Lab Tech III, Asst. Supervisor
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Dec 2000 - Dec 2004
Provided customer relations and quality control focusing on processing samples intended for testing of biological materials for a wide range of diseases in animals for national and international organizations. • Functioning as department supervisor, developed and implemented SOP’s, provided performance evaluations, facilitated training and hiring of new employees.• Professionally interacted with clients to coordinate sample submission and diagnostic services.• Collaborated with colleagues to ensure samples are processed accurately and tested according to schedule.• Processed diagnostic samples for animals and/or biological materials intended for export through the regulatory affairs unit. • Coordinated sample referral to other laboratories and universities across the country.• Performed data entry in the laboratory management system (UVIS). Show less
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Education
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2000 -
Cornell University
Bachelor of Science - BS, Animal Science -
2020 - 2023
San Diego State University
Master of Science - MS, Regulatory Affairs
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