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DHF Remediation-Medical Devices

Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
Massachusetts (USA)

Offer summary

Qualifications:

5+ years of medical device experience, Experience with U.S. product launches, Strong Design Controls background, Regulatory experience preferred, Mechanical or biomedical engineering degree.

Key responsabilities:

  • Review and update electronic DHFs
  • Identify and fill missing gaps
  • Evaluate content of DHFs
  • Create new DHFs as needed
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:
  • Our medical device client north of Boston, MA needs a Product Development Engineer with 5+ years of medical device experience to go through all electronic DHFs to ensure they are all updated, complete, and accurate.
  • Some may be missing; some may need strengthening.
  • Some may need to be created from scratch. Candidate would go in and evaluate all missing gaps.
  • Evaluate the content of each. Candidate should have experience with a few U.S. product launches and be strong with Design Controls.
  • Some regulatory experience is helpful. Having a mechanical or biomedical engineering degree is a big plus for this role.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

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