Regulatory Affairs Specialist

  • Healthcare
  • Full time
  • 1 year ago

Job Information

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    No. of Openings 1 opening
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    Job Experience 5+ years
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    Education Level Bachelor
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    Location Restrictions USA only

Job Description

Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality solutions to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices. Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the “and means more.”

The Regulatory Affairs Specialist applies their knowledge to the delivery of regulatory and quality solutions to enable client success. The Regulatory Affairs Specialist delivers work products and executes the defined consulting scope of work with minimal oversight by experienced consultants. We have multiple levels and roles available.

Key Areas of Demonstrated Competence: 5 R&Q Knowledge Areas Depending on the individual client assignment(s), the Principal Specialist may perform the following essential duties:

  • Provides daily hands-on regulatory and quality support to clients under minimal supervision of an experienced consultant
  • Completes the drafting of worldwide regulatory strategies and worldwide regulatory submissions with minimal supervision
  • Conducts Quality System Development programs as well as Quality System improvement programs with minimal supervision
  • Conducts quality audits and completes audit preparation of clients
  • Conducts design assurance activities: safety risk management, usability, design verification and design validation with minimal supervision
  • Conducts process validation and other related quality manufacturing tasks with minimal supervision
  • Identifies supplier quality specifications and completes supplier qualification activities
  • Conducts supplier audits with supervision and direction from an experienced consultant
  • Conducts post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities under minimal supervision
  • Prepares recall activities as directed by an experienced consultant

Project Resource Responsibility

  • Leads projects to ensure the customer is 100% satisfied with the project, fully communicated with, and that any issues are predicted prior to them actually arising. Must be able to understand the customer satisfaction level of the project at any given time
  • Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
  • Communicates project risks and issues to the project lead in a timely fashion
  • Leads increasingly complicated projects in accordance with the R&Q QMS Project Management Procedure
  • Works with manager and project lead to ensure all projects are on schedule and hitting cost targets, profit margin, and are in compliance with the R&Q Quality Management System

Education/Work Experience

  • Bachelor level degree required preferably in engineering, chemistry, physics, biology or related life science
  • 2-15 years related work experience
  • Minimum of 1 year of experience in the medical device industry required
  • Consulting experience preferred
  • Working knowledge of FDA Regulatory Regulations
  • EU MDR a plus

Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family. Make your impact today!

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.

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