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.

 
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.

 

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Paige are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.