Regulatory Affairs Manager

Organization
Ariosa Diagnostics
Job Location
5945 Optical Court
San Jose, CA 95138
Salary
DOE
Benefits

Standard Benefits

Job Description

 

Summary

 

The primary responsibilities include creating regulatory strategy for new products, managing filing related activities, providing regulatory expertise on daily issues, and interfacing with outside regulatory agencies.  Manage assigned product registration activities; including filing determinations, De Novo applications, PMAs, 510(k)s, Technical Documentation, IVDD, international product registrations, and annual license renewals, compile information from multiple sources for filing, guiding the project teams in creating documentation for submission, writing summaries and other necessary documentation for filing.  This position reports to the Ariosa Diagnostics Director of Regulatory Affairs & Quality.

 

 

 

Essential duties and Responsibilities

 

  • Represent Regulatory Affairs on project teams
  • Attend product project teams meetings, as necessary, providing regulatory guidance and review
  • Prepare annual facility establishment licensing renewals and product listings
  • Prepare necessary product registration renewals when required.
  • Establish quality system related procedures and policies for Regulatory Affairs
  • Possess a broad understanding of the quality system regulations (FDA & ISO) for medical devices
  • Develop regulatory strategies, templates and documentation for product registrations for each new or modified product
  • Assist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products
  • Actively participate with product risk management for medical devices teams
  • Provide guidance in complying with regulations; assist in developing rationale and documentation for new product development, design verification, product changes, testing, design reviews, labeling changes, packaging changes, material changes, etc.
  • Possess a broad understanding of medical device software requirements (device & process controls)
  • Possess broad understanding of design, product, and software validation requirements
  • Review and approve product labeling content
  • Review and approve ECO/DCOs, as necessary
  • Review and approve Marketing advertising and promotional materials
  • Assist with product safety determinations
  • Conduct Medical Device Reporting (MDR) and vigilance activities in a timely manner
  • Conduct product corrections and removals in a timely manner
  • Assist with interfacing with FDA on regulatory issues; Interface with international regulatory agencies
  • Participate with internal & external audits
  • Work with Quality, Engineering, and Marketing to ensure product supply
  • Other duties may be assigned

 

Requirements

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

  • RAPS RAC a plus
  • ISO 13486 Lead Auditor, a plus
  • 5-8 years in a regulatory role at a medical device company
  • Extensive experience in performing all regulatory functions such as writing 510(k)s, filing, reviewing documentation for regulatory compliance, interfacing with FDA, international regulatory agencies (Canada, EU, Japan, China Brazil) as well as ISO notified bodies
  • Software-related regulatory experience
  • Extensive experience with maintaining Technical files
  • In depth knowledge of FDA regulations
  • Computer skills including Word and Excel
  • Ability to work independently
  • Team player – project team experience
  • Ability to do research and come up with creative solutions for regulatory challenges
  • Excellent writing skills and ability to synthesize information to present internally as well as to regulatory agencies
  • Demonstrated leadership; attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects simultaneously

 

Education

  • BS in Engineering or Science or equivalent
About Our Organization

Ariosa Diagnostics, Inc., is a molecular diagnostics company committed to innovating together to improve patient care. The flagship product, the Harmony Prenatal Test, is a safe, highly accurate and affordable prenatal test for maternal and fetal health. Led by an experienced team, Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood. The Harmony test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

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