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Senior Specialist/ Engineer- Regulatory

Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality support 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.” 

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 and join the Boston Team!

Job Summary: The Senior Specialist, or Engineer contributes to the delivery of regulatory and quality solutions to enable client success. The Senior Specialist prepares work products and executes the defined consulting scope of work, with assistance of more experienced consultants as needed. 

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

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

Project Resource Responsibility

  • Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
  • Communicates project risk and issues to the project lead in a timely fashion Sales and Marketing
  • Identifies potential new customers, builds relationships with existing customers, pursues conversations regarding R&Q capabilities, and creates connections for the Sales Team

Education/Work Experience

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science, advanced degree preferred
  • 2-5 years related work experience ·
  • 1-3 years of medical device industry experience required · Consulting experience preferred
  • Working knowledge of FDA Quality System Regulations required
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