Jacob Ramirez Email & Phone Number

Las Vegas, NV, US

Bedford, MA, US

• Medical Devices: Hyaluronic Acid Pain Injections – FDA Class III / EU Class III / Health Canada Class 4, Class 3Drugs: Hyaluronate Sodium Pain Injection (equine osteoarthritis) – CVM Animal DrugResponsible for filing.
• Prepare, submit, and archive 510(k)s, Letters to File, EU MDR Technical Documents, & Change Notifications. Correspond with the FDA and EU Notified Body to address submissions, queries, letters, etc.
• Complete regulatory activities for post-launch business maintenance - including FDA Annual Reports for Anika’s FDA Class III PMA (Premarket Approval) devices & CVM Animal Drug.
• Supply regulatory insight for numerous product and equipment related Change Controls. Activities consist of performing Regulatory Assessments, completing necessary submissions, and reviewing affected.
• Bedford Capacity Expansion: Provide instrumental regulatory support for major manufacturing facility project that allowed for an increase in product throughput capacity while providing supplementary equipment for.

Westwood, MA, US

• Medical Devices: Wound Closure Sutures – FDA Class II / EU Class III, Class IIb / Health Canada Class 3Supported the implementation of Corza’s international regulatory strategy via the compilation, review, and.
• Authored the revisions of the Technical Files for Corza’s 17 major product brands to EU MDR 2017/745 compliance and functioned as project manager for the submission and review process with the Notified Body.
• Represented the Regulatory Affairs team as the point person during a successful EU MDR Notified Body audit that resulted in zero findings.
• Oversaw global regulatory activities for the Quill brand – Polyglycolic Acid/Polycaprolactone, Polydioxanone, & Polypropylene barbed sutures with varying absorption profiles. Activities comprised of regulatory.
• Managed Corza’s Unique Device Identification (UDI) product compliance through GS1 while assigning GTINs for new SKUs/products before successfully training a team member to assume the role.
• Lead discussions and represented RA on project teams to develop and recommend appropriate regulatory approaches.

Iselin, New Jersey, US

• Assisted Scientific Affairs with numerous testing procedures regarding product compliance & customer complaint management. Responsibilities included chemical solution synthesis, chemical permeation analysis, physical.
• Expert at Organic, Inorganic, Analytical, and Biological chemistry. Adept in a wide variety of complex chemical and biological lab techniques including chromatography, spectroscopy, chemical permeation analysis, and.

Iselin, New Jersey, US

• Medical Devices: Examination & Surgical Gloves – FDA Class I / Health Canada Class 2Provided regulatory support via the compilation of medical device information and documentation to ensure regulatory compliance of.
• Wrote and submitted 5 medical device FDA 510(k) (Premarket Notification) submissions to assist in new product development.
• Principal supervisor of all National Fire Protection Association (NFPA) certifications for Ansell’s Hazardous Material Protective Clothing & Single Use Glove portfolios. Also presided over supplementary product claims.
• Managed Ansell’s Unique Device Identification (UDI) product compliance via GS1 and successfully uploaded all products to the FDA’s Global Unique Device Identification Database (GUDID).
• Sought continuous improvement of RA processes by developing guidelines and templates to facilitate efficient and compliant submissions, certifications, & post-registration modifications. Assisted in the implementation.
• Created a restricted substance database to track product compliance to hazardous substance regulations such as Proposition 65, EU REACH, Toxic Substances Control Act (TSCA), & Conflict Minerals. Conducted annual.

Iselin, New Jersey, US