Medical Director

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Description:

Bluejay Diagnostics is a rapidly growing medical device company focusing on rapid near-patient diagnostics. We strive to innovate in ways which completely change the medical decision-making process, ushering in a new era of healthcare. To help us with our mission, we are searching for a Medical Director. This person will work with a multidisciplinary team to strategically influence R&D, marketing, and regulatory activities.

Responsibilities:

  • Development of Market Requirement Documents.
  • Development of Essential Requirements.
  • Maintain medical licenses (board certifications) and keep current with medical practices.
  • Assist in clinical protocol development and regulatory filings.
  • Serve as medical contact for company.
  • Present and write reports.

Requirements:

  • MD or equivalent.
  • Minimum of 3 years of experience in the medical device industry, point-of-care devices and IVDs preferred.
  • Medical licensure in good standing.
  • Strong knowledge of regulations related to Medical Affairs.
  • Excellent written and verbal communication skills.
  • Experience running clinical trials with knowledge of GCP.
  • Ability to travel both domestically and internationally (~25%).
  • Board certification (preferred).
  • Understanding applicable regulatory requirements including FDA QSR and ISO 13485 (preferred).
  • Experience with product development lifecycle (preferred).
  • Ability to commute/relocate to our Acton, MA office (Preferred).
  • Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject review between employee and manager throughout tenure.

Benefits:

  • Paid time off
  • Health insurance
  • Dental Insurance
  • Vision insurance
  • Parental leave
Industry: Medical Device and In Vitro Diagnostics
Job Type: Full Time

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