Position Title: Sr. Staff Regulatory Affairs Specialist Job Location: Fremont, CA
Department: Regulatory Affairs Worker Category: Full-Time
About Q’Apel:
At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where Q’Apel comes in.
Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy which requires an all-hands-on-deck attitude, taking on all the changes with excitement and a great attitude.
Who We Want:
Q’Apel is looking for a Sr. Staff Regulatory Affairs Specialist who possesses a strong passion for their work and a robust drive to achieve success. They must demonstrate the ability to work independently with minimal supervision, showcasing a history of successfully obtaining regulatory clearances in key markets such as the US (FDA) and various international regions including Taiwan, Korea, Japan, Canada, Brazil, Mexico, Australia, Israel, Iraq, KSA, Turkey, Russia, and Southeast Asia. Familiarity with EU MDR is essential, as the role involves preparing technical documentation for CE Certification submissions to notified bodies. Additionally, proficiency in EU MDR's Post Market Surveillance requirements is required, demonstrated through the creation of essential documents such as CER, PMCF, PSUR, SSCP, and PMS Plan. The candidate should also be prepared to collaborate with other members of the Regulatory Affairs team, providing strategic advice and guidance to ensure successful submissions across diverse regulatory environments.
What You’ll Work On:
- 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.
What You Bring:
Education:
Bachelor’s degree in science.
Experience & Skills:
- A minimum of 7 years of regulatory experience is required in the medical device industry.
- Prefer 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.
- RAC certification preferred.
- International work experience a plus.
- Having Notary Commission is a plus.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company, your performance, contributions, and results along with business and organizational needs, will affect your base salary. The base salary range for this full-time position is between $140,000 to $170,000 + equity + benefits.
This document contains confidential, proprietary information of Q’Apel Medical, Inc. It may not be copied or reproduced without prior written permission from Q’Apel Medical, Inc
