Vice President of Quality Assurance & Regulatory Affairs
Company: SupportFinity---
Location: San Francisco
Posted on: October 12, 2024
Job Description:
Title: Vice President of Quality Assurance & Regulatory
AffairsCompany: Neptune MedicalNeptune Medical is a Silicon Valley
based, venture capital funded, medical device start-up. Using our
proprietary Dynamic Rigidization technology we are designing,
building, and commercializing category-defining next-generation
manually and robotically operated systems for flexible endoscopy.
We have a fantastic team, technology, and investors.POSITION
SUMMARY:The company is seeking an experienced VP of QA & RA. The
individual will be a core part of the executive team and
responsible for determining and achieving the company's quality and
regulatory goals.In this role, you will maintain and improve the
quality system and design control processes for the existing
(manually operated) commercial product while also implementing and
building out design controls and quality processes for the
in-development robotic platform.You will have responsibility for
ensuring high quality products and quality management system
processes to support clinical and commercial use of company
products. You will serve as the Quality System Management
Representative, including hosting regulatory authority audits, and
Person Responsible for Regulatory Compliance (PRRC).Additionally,
in this role you will coordinate and work with a number of outside
regulatory consultants to implement Neptune's regulatory strategy
across its diverse product lines.The ideal candidate will display
the ability to perform with a high level of individual
responsibility and leadership. This leader will act with passion,
intensity, integrity, inventiveness, and urgency as the leader of a
VC-funded medical device start-up that is fast-paced,
collaborative, and driven to change standards for medical care. For
the right person, this position will be a tremendously exciting and
career-defining opportunity, making core contributions to an
existing commercial product line and a genuinely new type of
medical robotic platform.Essential Job Duties and
Responsibilities:
- Develop, implement, and maintain the company's quality
assurance and regulatory strategy to ensure product safety and
efficacy and support business objectives.
- Ensure that staff are recruited, hired, trained, managed and
led to meet current and future requirements.
- Generate, and manage the department budget.
- Work closely with product development and manufacturing staff
to ensure adherence to quality assurance procedures and
requirements and to ensure that products meet reliability and
quality expectations, including international quality management
system regulations and ISO 13485.
- Hands-on responsibility for quality management system and
regulatory compliance, including, but not limited to: document
control, design control, risk management, verification/validation,
manufacturing controls, personnel training, quality audits,
supplier evaluation, equipment calibration/maintenance, product
inspection/testing, nonconforming product control, product
complaints, post-market surveillance, corrective/preventive
actions, environmental monitoring, product sterilization, product
installation, and product servicing.
- Lead periodic management reviews and report to top management
on quality system performance and any need for improvement.
- Manage internal quality audits and external regulatory
inspections.
- Establish quality inspection procedures and statistical
sampling plans. Ensure that appropriate inspection and test
equipment is obtained and properly used for inspections and
tests.
- Lead nonconforming product review activities to efficiently
disposition affected material.
- Investigate causes of nonconforming products and implement
effective corrective actions.
- Lead the product complaint process.
- Direct regulatory authority submissions for marketing
authorization and changes.
- Support regulatory authority post-market vigilance
reporting.
- Analyze product complaint and post market surveillance data and
prepare summary reports.
- As Person Responsible for Regulatory Compliance, ensure
conformity of devices and company's compliance with applicable
state, federal, and international regulations and standards.
- Recruit and manage an appropriate mix of internal staff and
consultants to supply appropriate expertise and bandwidth to
execute the regulatory strategy.Required Education and Experience:
- BS in engineering or scientific discipline. Advanced degree
preferred.
- Minimum 15 years of medical devices quality assurance and
regulatory experience.
- Minimum 10 years of experience in Director and VP roles.
- Experience with bringing a product through a full regulatory
cycle.
- Experience with complex capital equipment as well as disposable
medical devices.
- Proficient with the design, implementation and maintenance of
quality management systems for medical device development,
manufacturing, distribution, and post market surveillance.
- Proficient with international medical device regulations and
standards.
- Proficient with application of statistical techniques for
manufacturing and quality systems.
- Excellent oral communication, written communication, and
presentation skills.
- Experience recruiting, managing, retaining, motivating and
leading diverse, high-performance teams, creating a workplace where
team members do their best work in pursuit of an ambitious
vision.
- Willingness to work hard with a strong desire to succeed as an
individual and as a team leader.
- Ability to work effectively with the CEO, board of directors
and senior management team.
- Ability to stay ahead of pending regulation, guidance and
standards revisions, deadlines, and trends.
- Ability to drive decisions around changes and improvements by
considering the tradeoffs.
- Experience with FDA and EU MDR regulatory processes.Preferred
Experience and Qualifications:
- Experience with electromechanical software-controlled medical
devices (E.g., robotics).
- Experience with software development life cycle controls (IEC
62304).
- Experience with medical electrical equipment safety standards
(IEC 60601 series).
- Experience with medical device usability evaluation (IEC 62366
series).
- Experience with medical device capital equipment
servicing.
- Experience with advanced catheter manufacturing.
- Experience with sterile disposables and consumables.
- Hands on experience supporting advanced catheter manufacturing
is highly desirable.
- Experience with, and comfort within, a fast-growing
start-up.
- Experience as a pivotal part of a team that developed products
from invention to scaled market release.
- Certification by recognized quality organizations (e.g., ASQ -
American Society for Quality).Our headquarters is in Burlingame, CA
adjacent to the Millbrae BART and Caltrain stations. We are
primarily a work from office company.The starting base salary for
this role is between $275,000 and $325,000 depending on experience.
The actual base pay is dependent upon many factors, such as:
education, training, transferable skills, work experience, and
business needs. The base pay range is subject to change and may be
modified in the future. This role may also be eligible for equity,
benefits and 401(K) with matching.Neptune Medical provides equal
employment opportunities to all applicants for employment and
prohibits discrimination and harassment of any type without regard
to race, color, religion, age, sex, national origin, disability
status, genetics, protected veteran status, sexual orientation,
gender identity or expression, or any other characteristic
protected by federal, state or local laws.
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Keywords: SupportFinity---, Fremont , Vice President of Quality Assurance & Regulatory Affairs, Executive , San Francisco, California
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