JOB DESCRIPTION

Partial Job Description

1) Provide regulatory and device development guidance to company pharmaceuticals and assist in the implementation, maintenance and adherence to the quality systems required for the development of medical devices

2) Develop and maintain document management, electronic publishing and web-based/electronic clinical trial systems

3) Ensure for all in-house regulatory aspects of the clinical studies being performed by company as they relate to the development of medical devices

4) Ensure for maintaining quality and ensure that studies, documents and submissions to the federal agencies meet required industry and federally specified standards (Good Clinical Practices)

5) Develop and maintain company device SOPs

6) Ensure design control procedure is followed for each medical device

7) Ensure design and development of all medical device products planned and controlled

8) Maintain up-to-date design plan

9) Ensure plan reviewed, updated and approved as the product development evolves

10) Maintain the design history file

11) Coordinate design reviews at the appropriate stages and intervals

12) Manage and prepare all device regulatory submissions

13) Ensure final review and sign-off of investigator regulatory packages for device shipment for device clinical trials

14) Interact with FDA and other regulatory bodies

CRITICAL REQUIREMENTS

• Qualifications / Skills Required

  
  

  1) BS or healthcare in related field

  
  

  2) Experience of 1 - 2 years in regulatory in device development

  
  

  3) Experience in dental product development (preferred)

  
  

  4) Ability to multi-task and successfully handle multiple priorities simultaneously

  
  

  5) Willingness to travel (Flexible to overnight travel)

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION