Director of Regulatory Affairs & Quality

| Remote
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Paige is a software company helping pathologists and clinicians make faster, more informed diagnostic and treatment decisions for patients with cancer by leveraging decades of data from the world’s experts in cancer care. We are leading a digital transformation in pathology with advanced Artificial Intelligence (AI) technology to create value for the oncology team. 

Paige is the first company to develop clinical grade AI technology for the pathologist, which resulted in our receiving FDA breakthrough designation for our first product.

We are seeking a passionate Director of Regulatory & Quality to join our team. You must have the knowledge and experience to understand the appropriate regulations, with the passion and capability to implement a QMS in a lean method suitable to an agile software development organization. As Director of Regulatory & Quality, you will be working closely with key stakeholders across the company, you will be responsible for driving and managing regulatory strategy and obtaining regulatory approvals across a range of products as well as maintaining and improving our quality management system. This position requires ensuring compliance with existing and upcoming regulations applicable in the US, Europe and South America. You will be responsible for working closely with leadership to align regulatory strategy with product strategy. This is an excellent opportunity as a hands-on, yet strategic, position in a dynamic and fast-growing company.


This position can be fully remote for U.S. based applicants living outside of the NYC area. 


Key Responsibilities:

 
Regulatory Affairs

  • Create and execute Regulatory Strategies and Plans for assigned products in the domestic and international markets.
  • Support and provide regulatory expertise to assigned product development projects.
  • Maintain expertise in the interpretation of domestic and foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products.
  • Prepare and submit 510(k)'s, IDE's, registration and listing, and other product submissions according to FDA guidelines as well as any required reporting.
  • Creating Technical File and Declaration of Conformity documents and other relevant regional submissions according to IVDD and other international guidelines.
  • Review and approve product labeling plans, labeling, and marketing communications and assure claims are substantiated.

 
Quality Assurance and Quality Control

  • Manage and improve the Paige Medical Device Quality Management System (QMS) function ensuring compliance with applicable laws, regulations, and standards for a medical device
  • Verify and maintain quality control records and documents.
  • Establish and actively direct quality management sub-systems to achieve continual compliance and consistency that include: Deviations, CAPA, Document Control, Process control, Supplier management, Training, etc
  • Perform internal quality management reviews and internal audits to ensure the Paige QMS remains compliant with national and international standards for medical devices.
  • Provide guidance and participate where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.
  • Recommend and coordinate implementation and effectiveness of any resulting or otherwise needed corrective and preventive actions.
  • Facilitate audits by external auditors and certifying bodies to verify compliance of quality management system, security, risk and other required standards.
  • Work with the rest of the Paige team to implement and maintain a process for continual improvement of customer satisfaction, product and service quality, and process performance.
  • Ensure personnel are trained and competent to perform their role(s) and capable of producing quality products.
  • Perform quality orientation and quality trainings to staff throughout the year, as needed.

 
Qualifications and Experience

  • ABS or equivalent in Engineering, Life Sciences or other similar technical field. Master’s degree preferred. Regulatory Certificate or RAC preferred.
  • Minimum of 6-8 years of experience within Medical Device industry. Duties and tasks reflect variety and complexity. 
  • Excellent knowledge of ISO13485, ISO27001, EU and FDA requirements, with experience supporting regulatory submissions and technical files.
  • Proven track record of preparing for and managing successful Quality audits/inspections.
  • Quality system and regulatory experience with Software as a Medical Device (SAMD) preferred.
  • Experience with LDTs preferred.
  • Experience with clearance of medical devices outside of the US and the EU preferred.

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Technology we use

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Location

Were located in the heart of Manhattan NYC, one of the world's great cities.

An Insider's view of Paige

What are some social events your company does?

We sit down each day together for lunch, which is a great opportunity to catch up! Every Friday we come together for a TGIF session to discuss the week.
We do an offsite team building activity at least once a month.
Team members play soccer, table tennis, Mario Bros. and go rock climbing together.

Helen

People and Operations Manager

What does your typical day look like?

My day is the perfect balance of developing new functionality into our products, testing and improving recently developed software, thinking and experimenting on open-ended problems and discussing with the AI team about ongoing and prospective tasks. We also gather everyday to discuss any challenges and to support anyone facing obstacles.

Sheena

AI Engineer

What makes someone successful on your team?

As a company fundamentally developing new technology, we are continually faced with challenges that don't have any precedent in science or industry. The ability to rise to that challenge and develop creative and innovative solutions is critical to our success.

Brandon

Senior AI Scientist

What is your vision for the company?

Paige will have a transformative impact on patient cancer care by improving pathology quality, throughput, costs and by enabling new biomarkers and diagnostics. Our powerful technology will be implemented in hospitals around the world, will help biopharma to more effectively treat their patients and bring new cancer therapies to market faster.

Leo

CEO

What are Paige Perks + Benefits

Culture
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Diversity manifesto
Mean gender pay gap below 10%
Health Insurance & Wellness Benefits
Dental Benefits
Vision Benefits
Health Insurance Benefits
Wellness Programs
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Acme Co. hosts company outings Monthly.
Free Daily Meals
Stocked Kitchen
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Lunch and learns
Cross functional training encouraged
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