Regulatory Affairs Specialist

Julia Savina

REGULATORY AFFAIRS SPECIALIST

Morrisville, NC

T: 919-***-**** @: adlf2b@r.postjobfree.com linkedin: isavina

Core qualifications

SOFT SKILLS

• Strong attention to detail, great organizational and time management skills.

• Horizontal networking with specialists in the field.

• Analytical and problem-solving skills.

REVIEWED THE FOLLOWING DOCUMENTS

• Certificate of incorporation, Power of attorney; CE, ISO certificates, Declaration of Conformity, Free sale certificate

• User manual, technical file, STED, test reports, MSDS, blue prints, RMF, labels (design dossier).

• CER, clinical articles, clinical review, safety monitoring reports.

SUPPORTED PRODUCT APPROVALS FOR

• Circassia Pharmaceuticals: NIOX VERO® Airway Inflammation Monitor and its accessories (Class: I MD & “Other” IVD)

• Merit Medical: Diagnostic Guide Wires, Insertion Devices, Baloon Catheters, Inflation Devices, Cetral Venous Catheters, Drainage Catheters,

Radial Compression Devices, Introducer Systems, Drainage Accessories, Embolization particles, Tumor Ablation System (Class: I, IIa, IIb, III)

• BTL Industries: Physiotherapy & Aesthetic Devices, including Microwave & Shortwave diathermy, Laser & Ultrasound therapy (Class: IIa, IIb)

• Medtechconsulting: Medical Imaging & Radiology Devices, including MRI, CT, RX; PACS, Radiopharmaceutical synthesizer (Class: IIa, IIb).

Experience

Circassia Pharmaceuticals, Inc. Morrisville, NC

REGULATORY AFFAIRS MANAGER, GLOBAL (CONTRACT) Mar 2020 - Oct 2020

• Supported international registrations and renewals for EMEA, CIS, Mexico, Taiwan.

• Established and maintained Technical Files, DoCs, GSPR documents under MDR/IVDR requirements.

• Reviewed product changes for impact to regulatory submissions.

• Provided input on Regulatory requirements, compiled regulatory overview for APAC, EMEA, LATAM.

• Conducted GAP analysis for Technical Files under MDR/IVDR.

• Managed 6 ongoing projects.

Merit Medical Systems Inc. Moscow, Russia

REGULATORY AFFAIRS SPECIALIST II Jul 2017 - Jun 2019

• Regulatory filings for consulting companies, distributors and regulatory bodies.

• Monitored regulatory development to identify issues affecting ongoing operations.

• Provided regulatory guidance and feedback to various stakeholders.

• Developed regulatory strategies and lead implementations.

• Ensured quality system compliance.

• Managed 16 ongoing projects, maintained 10 completed projects.

BTL Industries Moscow, Russia

REGULATORY AFFAIRS SPECIALIST PROJECT MANAGER May 2016 - Jul 2017

• Developed a project strategy to ensure that the registration needs were met, risks were minimized.

• Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.

• Compiled and filed for licensing, patenting, declaration, certification, registration, and renewals to regulatory bodies.

• Assisted in the development and maintenance of regulatory files, records, and reporting systems.

• Managed 13 ongoing projects, maintained 15 completed projects.

Medtechconsulting Moscow, Russia

SR. REGULATORY SPECIALIST (MEDICAL DEVICES) Feb 2016 - Apr 2016

• Requested data from clients, prepared and submitted the dossier to authorities.

• Verified that incoming documents adhere to regulatory standards and requirements.

• Supported technical and toxicological testing, and clinical reviews, requested additional information based on feedback from labs and clinics.

• Provided regulatory guidance, reports, and support upon customer requests.

• Managed 25 ongoing projects.

Medtechconsulting Moscow, Russia

REGULATORY SPECIALIST (MEDICAL DEVICES) Aug 2015 - Jan 2016

• Negotiated with customers, interacted with regulatory bodies.

• Consulted clients and prepared the dossier for registration.

• Provided with information technical, toxicological and clinical departments.

• Evaluated key issues for discussion, managed different regulatory tables.

• Managed 18 ongoing projects.

Education

Samara State Medical University Samara, Russia

DOCTOR, MEDICAL AND PREVENTIVE CARE, GENERAL HYGIENE 2006 - 2013

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