Regulatory Affairs Manager
Resume:
928-***-**** Virginia Kostman ***************@******.**
Recent Experience
Senior Regulatory Affairs Specialist, surgical devices Integra LifeSciences, 1100 Campus Rd, Princeton, NJ 08540 855-***-**** Jan 2022 – Present
Assess design changes for regulatory impact
Identify, communicate, and consult on requirements for changes to legal manufacturer
Consult on labeling requirements
Update technical files to comply with European MDR
Manage regulatory aspects of onboarding distributed product Philips Healthcare, High Tech Campus 5, Eindhoven, Noord-Holland, 5656AE Netherlands 31-20-597**** Regulatory Affairs Manager, diagnostic devices
June 2020 – May 2022
Wrote regulatory submissions to China NMPA for patient monitors and accessories
Obtained and maintained regulatory clearance/approval in rest of world for design changes and new products Regulatory Affairs Specialist, diagnostic devices
Feb 2019 – June 2020
Acted as regulatory lead on class II electroencephalograph (EEG) product development project
Maintained regulatory strategy
Led team to identify means of complying with new European medical device regulation
Interacted with international RA reps
Served on change control board
Assessed proposed design and manufacturing changes for regulatory impact and requirements Regulatory Affairs Consultant, diagnostic devices
May 2018 – June 2019
Medtronic (Consulting role through Oxford Staffing, 900 Cummings Center, Suite 326T, Beverly, Massachusetts 01915, US) Provided regulatory advice and deliverables, including the following areas of expertise:
MDR remediation
Identified changes to regulation affecting class I, 2a, and 2b technical files
Identified harmonized standards applicable to company products
Led team in identifying gaps to the MDR in procedures and documentary evidence
Worked with team to create remediation plan for company-wide procedures and product-specific technical files
(including clinical evaluation protocols and reports)
REACH/ROHS/California Proposition 65 remediation and compliance
Clinical and regulatory strategy for product development
Provided input to regulatory strategy at early feasibility stage
Identified and communicated likely FDA questions surrounding clinical plan for combination product with complementary diagnostic
Senior Regulatory Affairs Specialist, IVD companion diagnostics March 2016 – April 2018
Ventana Medical Systems, 1910 E Innovation Park Dr, Tucson, AZ 85755 520-***-****
Wrote and published the following types of FDA submissions:
PMA modules (Manufacturing, Software/Hardware, Analytical, and Clinical)
PMA amendments/supplements
de novo application sections
Investigational new device exemption (IDE) applications/supplements
Treatment IDE applications
Annual reports for PMAs and IDEs
Presubs
Study risk determination (SRD) letters
Wrote the following types of internal regulatory documents:
928-***-**** Virginia Kostman ***************@******.**
Internal risk assessments
Modular PMA templates
A de novo application template
Compiled and applied regulatory intelligence from FDA responses and meeting minutes
Interacted cross-functionally with departmental leaders to collaborate on the incorporation of FDA expectations into the product development process
Analyzed design and manufacturing changes for impact to Class I, Class II, Class III, and IDE devices
Reviewed protocols and reports to ensure compliance with US regulatory requirements
Wrote regulatory plans and regulatory requirements for product development teams
Compiled documents to meet European requirements, including essential requirements checklists (ERC), technical documentation files (TDF), Annex VIII statements, and Declarations of Conformity (DoC)
Conducted gap analyses to ensure completeness and accuracy of PMA Quality System modules and Design History Files (DHF)
Quality Assurance, nutraceuticals
April 2015 – March 2016
Marlyn Nutraceuticals, 4404 E Elwood Ave, Phoenix, AZ 85040 480-***-****
Created environmental bioburden monitoring program
Attended and supported quality audits
Investigated quality and customer complaint issues
Reviewed product, packaging, and raw material specifications, releasing product only based on test results
Oversaw cGMP quality training for the entire plant and its personnel Quality Assurance Engineer/Technical Writer, medical device manufacturing, class II December 2013 – March 2015 (temporary position through Adecco, 602-***-****) Polymicro Technologies, 18019 N 25th Ave, Phoenix, AZ 85023, 602-***-****
Created, implemented, and managed top-notch systems for employee training, document control, vendor management, risk management, process validation, and process change
Utilized six sigma methodology
Responded to customer complaints and developed corrective or preventive actions (CAPA)
Participated in material review boards (MRBs)
Represented company during audits from customers
Performed internal audits
Oversaw outsourced sterilization
Wrote process validation reports for Quality Assurance and Regulatory purposes
Supervised Document Control department
Created, managed, and updated medical-device manufacturing and quality documentation to bring company into compliance with ISO 13485 and 21 CFR Part 820
Analyzed systems and suggested processes to improve efficiency and regulatory compliance in the following areas:
Document control
Vendor management
Manufacturing process validation and change
Received and responded to audit findings from medical-device customers
928-***-**** Virginia Kostman ***************@******.** Education and Skills
Six Sigma Green Belt Certification
American Society for Quality (ASQ)
ISO 13485 Lead Auditor Course (certificate of completion) British Standards Institution (BSI)
Professional Certificate in Regulatory Affairs (medical device) Regulatory Affairs Professional Society
Bachelor of Science, Biology (molecular and cell)
San Diego State University
Summa cum laude with special distinction
Undergraduate honors thesis completed under the supervision of Dr. Sanford Bernstein
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