Summary
Overview
Work History
Education
Skills
Certification
LANGUAGES
Timeline
Generic

Noa Dressler

Yokneam Hamoshava

Summary

Results driven Clinical and Regulatory specialist, with four years of experience in the medical device sector. Experienced in planning and execution of clinical studies while ensuring compliance with FDA and international regulations. Experienced in the approval process for new devices, including 510(k) submissions, PMA applications, and post-market surveillance. Skilled in developing regulatory strategies, conducting risk assessments, and collaborating with cross-functional teams to bring innovative products to market. Committed to maintaining high standards of quality and safety while positive relationships with regulatory agencies.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Clinical and Regulatory Manager

InMode Ltd.
01.2023 - 01.2025
  • Implemented Clinical Evaluations Reports (CERs) in accordance with EU-MDR regulations.
  • Supported the team in new submissions, renewals and post marketing activities.
  • Monitored clinical sites, including reviewal of reporting documentation, ensuring compliance with the protocol and sponsor SOPs, while addressing ethical and regulatory requirements.
  • Reviewed regulatory documents, registrations and technical reports including Benefit-Risk analysis, product V&V, with special attention to a variety of clinical data.
  • Working closely to the R&D, quality and marketing teams in order to ensure regulatory compliance.

Clinical Affairs Manager

Home Skinovations Ltd.
01.2021 - 01.2023
  • Company Overview: (former fellow subsidiary of InMode)
  • Maintained regulatory submissions, reports and technical documents for health authority approvals.
  • Overseeing site communication and collaboration, to ensure the smooth running of the trial and the well-being of participants.
  • Managed clinical studies including handling logistical challenges, time management, prioritization and regulatory compliance.
  • Reviewed patients’ concerns, customer complaints and adverse events, related to the device.

Pharmacovigilance (PhV) Associate

Teva Pharmaceuticals Industries
01.2018 - 01.2021
  • Monitored and analyzed safety data reports on suspected adverse reactions to medicines.
  • Led staff trainings, clinical projects and events including seminars, workshops, professional lectors and conferences.
  • Supported my team in several regulatory audits and health authority’s inspections.

Education

Master of Science - Clinical Nutrition

Tel-Hai Academic College
01.2016

Bachelor of Science - Clinical Nutrition

Tel-Hai Academic College
01.2013

Skills

  • Auditing expertise
  • Regulatory submissions
  • Global regulatory compliance
  • Training and mentoring
  • Patient safety
  • Quality improvement
  • Clinical documentation
  • Self motivation
  • Analytical thinking
  • Strategic planning
  • Problem-solving aptitude
  • Continuous improvement
  • Team collaboration
  • Organizational skills
  • Site management
  • Data analysis
  • Detailed documentation
  • Good clinical practice

Certification

  • CRA and GCP courses (Technion Inst. & GCP training center) 2024
  • Registered Dietitian (RD) (Rambam Health Care) 2016 - 2017

LANGUAGES

Hebrew - mother tongue
Fluent in verbal and written English

Timeline

Clinical and Regulatory Manager

InMode Ltd.
01.2023 - 01.2025

Clinical Affairs Manager

Home Skinovations Ltd.
01.2021 - 01.2023

Pharmacovigilance (PhV) Associate

Teva Pharmaceuticals Industries
01.2018 - 01.2021

Bachelor of Science - Clinical Nutrition

Tel-Hai Academic College

Master of Science - Clinical Nutrition

Tel-Hai Academic College

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Noa Dressler