VP Regulatory, Clinical Affairs and Quality Assurance in Fremont, California at QAPEL MEDICAL INC

Position Title: VP, Regulatory/Clinical Affairs and Quality Job Location: Fremont, HQ

Department: Q&R Management Worker Category: Full-Time

Job Class: Senior Management FLSA: Exempt

Industry: Neurovascular/Life Sciences/Medical Devices Job Function: Regulatory

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 that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Who We Want:

As a pivotal member of the senior leadership team, the Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will be responsible for leading and managing Regulatory Affairs, Clinical Affairs, and Quality Assurance to ensure the company is meeting US and EU requirements. Additionally, this role is responsible for leading regulatory compliance related to the continued commercial growth into new territories, including Japan, Canada, and other territories as required. The role is multifaceted and varied; it requires cross-functional project management skills and the ability to influence across the organization to drive regulatory affairs and compliance activities. Provides direction to the leadership team at Q’Apel Medical, Inc. and oversees regulatory activities to assure compliance to applicable federal and state regulations, international standards, and the company’s Quality Policy. Act as a liaison with regulatory agencies.

Performs the responsibilities and has authority within the organization as defined in the MDR 2017/745 for the Person Responsible for Regulatory Compliance (PRRC).

Vice President RACAQA position, reporting to the Chief Operating Officer, provides direction and leads all quality activities at Q’Apel Medical and assures compliance to applicable federal and state regulations, international regulations and standards, and the company’s Quality Policy. This includes leadership to assure compliance to the US Quality Systems Regulations, ISO 13485 (current) and the Medical Device Regulation (2017/745) including quality systems as defined in the company’s quality manual: Supplier controls, Equipment controls, Nonconformance control, CAPA, Complaint handling and adverse event reporting, Field actions, Document control, Training, Production and Acceptance activities, etc. Other activities include assuring the collection, analysis, and presentation of quality metrics of overall fitness and effectiveness of Quality Systems to management as well as status of initiatives in process and future improvement opportunities. The VP, QRA is responsible and has overall authority as the Management Representative to ensure the quality management system is suitable and effectively implemented at all times.

What You’ll Work On:

• Ensure regulatory compliance in accordance with MDR, Article 15
• Ensuring the conformity of the devices are checked per the applicable quality management system (QMS) requirement prior to product release.
• Technical documentation and EU declaration of conformity are completed and kept up to date.
• Post market surveillance obligations are met.
• Vigilance reporting procedures are followed.
• Investigational devices comply with the MDR, Annex XV, Chapter II, Section 4.1
• Responsibilities are defined procedures
• The PRRC shall suffer no disadvantage within the organization in relation to the proper fulfillment of duties.
• Authorized Representatives shall have permanent and continuous availability of the PRRC
• Drives the strategy for regulatory submissions of the company products for regulatory approval.
• Assures quality and regulatory objectives are defined, achieved, and maintained supporting company registrations and certifications.
• Supports the activities of the goals and initiatives of the company for overall suitability, effectiveness, and profitability of the company.
• Participates in the company’s Executive Management Review process.
• Serve as Q’Apel’s Management Representative as defined in the Q’Apel Quality Manual and Management Review Procedures.
• Supervise RA personnel and ensure personnel development through assessment of training and professional development needs.
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
• Support and provide input to Q’Apel’s Quality Policy and Quality System.
• Led the establishment and growth of the Quality department to support corporate, departmental, and regulatory objectives.
• Monitor activities supporting the goals and initiatives for the overall suitability, effectiveness, and profitability of the company.
• Establish a robust quality system to assure compliance with FDA QSR, ISO 13485:2016, the Medical Device Regulation, and other standards as applicable. Assure company objectives are defined, achieved, and maintained supporting company registrations and certifications.
• Executes the company’s Executive Management Review process.
• Leadership of Quality personnel to ensure personnel development through assessment of training and professional development needs.
• Responsibility and authority to release product to Q’Apel’s customers.
• Leadership to develop and review policies and procedures to ensure appropriate checks and balances are included to ensure a quality output.
• Drive best practice activities aimed at continuous improvement of business practices, systems, processes, and products through a team approach.
• Leadership of Quality department to ensure departmental and company objectives are achieved in a timely manner.
• Supervision: Leadership of Quality Operations, Quality Engineering, and Quality Compliance functions and related personnel as required.
• Safety: Performs job functions in a safe and effective manner. Ensures that employees under supervision are adhering to the safety procedures of the company.
• 0ther Duties: As assigned.

What You Bring:

Education & Experience:

• BS/BA degree in biology, engineering, or an equivalent scientific discipline.
• A master’s degree in biology, engineering, or an equivalent scientific discipline is preferred.

Knowledge and Skills:

• Strong business acumen with a focus on providing world-class experience at all levels.
• Minimum of 15 years of experience in a senior leadership role or related experience in the medical device industry. Neurovascular/ vascular device experience preferred.
• Minimum of 15 years’ experience managing Regulatory Affairs, Clinical Affairs, and Quality Assurance teams of non-exempt and exempt employees.
• Expert knowledge of Regulatory, Quality Operations, Quality Engineering, and Quality Compliance functions.
• Expert knowledge of FDA QSR, ISO 13485:2016
• Expert knowledge of investigational devices compliance with the MDR, Annex XV, Chapter II, Section 4.1
• Expert knowledge of current US Quality Systems Regulations, ISO 13485 and the Medical Device Regulation (2017/745) including quality systems as defined in the company’s quality manual: Supplier controls, Equipment controls, Nonconformance control, CAPA, Complaint handling and adverse event reporting, Field actions, Document control, Training, Production and Acceptance activities, etc.
• Exceptional strategic, written, and verbal communication skills to convey detail and analytical problem-solving solutions.

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, exempt position is between $200,000 to $350,000 + 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.