Remote: Regulatory Consultant (231394)

Life Sciences & Technology | Regulatory Affairs
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Job Description:

Our medical device client is looking for a Regulatory Consultant for a 1+ year contract. The Regulatory Consultant will assist in the preparation and EU MDR submission for neuro devices and include electrosurgery forceps, long term and short term antimicrobial catheters, patties/strips, and perforators/drills. They will be responsible for reviewing change orders associated with the MDR project deliverables. They must have EU MDR experience, including knowledge of RA requirements and experience preparing MDR submission for EU Class II and/or III devices. This person will actively participate with the EU MDR core team by attending meetings, collaborating with cross-functional stakeholders, and communicating RA requirements/guidance for submission. Combo-product experience is a plus.

Required Experience:

  • Education: Bachelor’s Degree required
  • Minimum 5 years of experience in the medical device industry is preferred

 

 

Remote: Regulatory Consultant (231394)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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