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Q'Apel Medical · 1 day ago

Sr. Staff Regulatory Affairs Specialist

Fremont, Fremont, CA, US

Full-time

Onsite

Senior Level, Lead/Staff

$140K/yr - $170K/yr

6+ years exp

Q’Apel Medical is a company focused on revolutionizing neurovascular access through innovative device technology. They are seeking a Sr. Staff Regulatory Affairs Specialist to prepare regulatory filings, support international registrations, and ensure compliance with various regulatory standards.

Health CareMedicalMedical Device

Responsibilities

Prepare regulatory filing including 510(k), Q-submissions and 513(g)

Support labeling materials in all forms to follow US and foreign regulations including translations to support foreign submissions

Collaborate on the strategy development for international product registrations in Latin America, Middle East, Russia, and Asian countries as required to support business needs

Monitor and maintain FDA Establishment Registration, Health Canada license, FDB license, and other OUS licenses as required

Support effective Post Market Surveillance activities in compliance with FDA and EU MDR requirements

Execute the compilation and maintenance of Q’apel Technical Documentation in compliance with the EU MDR

Monitor and maintain current knowledge of applicable regulatory literature and standards

Collaborate on the strategy development for document preparation for OUS submissions – notary, legalization, apostille and certification

Support company goals and objectives, policies and procedures, Good Clinical Practices, Good Manufacturing Practices, and FDA regulations

Ensure compliance with applicable Quality System Regulations, Medical Device Regulations (i.e. EU MDR 2017/745, ASEAN), ISO Standards (including, but not limited to 13485, 14971, 11135, 10993), and MDSAP regulatory requirements

Perform other duties as assigned

Qualification

Regulatory experienceNeurovascular DevicesEU MDR regulationsISO 13485 2016FDA 510(k) submissionsComputer literacyRAC certificationInternational work experienceNotary CommissionCommunication

Required

A minimum of 6-7 years of regulatory experience in the Neurovascular Devices Industry, Neurointerventional Devices Market, Endovascular Neurosurgery, Neurointerventional, Coronary or Peripheral Medical Device Sectors is required to be considered

Strong knowledge of ISO 13485:2016, EU MDR 2017/745, MDSAP, ISO 14971

Must possess excellent written and verbal communication skills

Computer literacy in Microsoft Office Suite is required

Demonstrate the ability to work independently with minimal supervision

History of successfully obtaining US FDA 510(k) regulatory clearances

Global regulatory strategy development and submission proficiency in Europe as well as various international regions, such as Asia, Canada, Eastern Europe, Middle East and Latin America

Familiarity with EU MDR regulations are essential

Collaborate with other cross-functional core team members to provide strategic advice and guidance to ensure successful submissions across diverse regulatory environments