<![CDATA[Legacy MedSearch: jobboards]]> http://JOBS.LEGACYMEDSEARCH.COM/ en-us <![CDATA[Director Regulatory Affairs]]> Director of Regulatory Affairs – Disruptive Early Stage Surgical Medtech

-Robotic, AI, VR, MR, Surgical Navigation, Imaging Computer-Assisted Surgery experience preferred  Start-up experience and/or entrepreneurial orientation required

A venture-backed start-up company with seasoned management and positive prior exit experience and recent FDA clearance is seeking an Senior Regulatory Affairs Leader to help the company prepare for successful commercialization. This is one of the start-up companies that has been in the news for its disruption and innovation.

The Director / Senior Director will develop and manage the company's Regulatory Affairs and Compliance and have oversight of the Quality Assurance program.   The position plays a key role in assuring the streamlining and decision analysis for proper regulatory pathways and quality plans are incorporated early in the product and business development process.

Position Responsibilities:

  • Communicating and interacting with the FDA, Notified Bodies, Authorized Representatives and Competent Authorities for maintaining and managing the Device Registrations, Compliance Inspections, Remediation, Field Actions, MDR and Vigilance Reporting processes
  • Develop long-term strategic plans and resource requirement for the global regulatory approval of product portfolio, to include the US,  EU, China, Japan, Latin America APAC, and ROW
  • Develop, direct and review product labeling for device registrations, sales and promotional purposes
  • Prepare and Submit pre-market clearance (510(k)) applications to the FDA, including developing and submitting appropriate responses to FDA requests for additional information.
  • Oversee and participate in the creation, provision, and distribution of regulatory documents (procedures, notes-to-file, submissions, etc.)
  • Act as a consultant to Executive Management and BOD in regulatory issues and is proactive in making developing strategies for impending product or regulatory issues that present an opportunity or  risk to the business.
  • Select, develop and manage a team of regulatory and quality professionals. Set high standards and hold employees accountable for achievement of stated objectives.

Position Requirements:

  • Director (12+ years) Senior Director (15++ years) of Regulatory experience, including experience in a small start-up or disruptive company environment (fast-paced, entrepreneurial)
  • Experience with 510(K) submissions, IDE clinical studies, and 21 CFR 820
  • Experience documenting and testing and understanding complex mechanical / technical systems
  • Previous experience as product development engineer in medical device is preferred
  • Experience with international standards like CE marks and ISO 9000 preferred
  • Excellent communication skills, an entrepreneurial “hands-on” leadership style
  • Start-up experience in medical devices with complex Mixed, Augmented, and/or Virtual Reality Robotic, Artificial Intelligence, Diagnostic or Therapeutic Imaging, Surgical Navigation, Computer-Assisted Surgery experience preferred, not required.
  • Experience as an engineer in a medical device or regulated environment preferred, not required

Educational Requirements:

  • Bachelor’s degree (Regulatory, Quality or Engineering or technical preferred, not required)
  • Master’s Preferred
  • RAPS, RAC certification preferred

Base plus commission: Highly competitive; Commensurate with experience
Travel: Minimal
Direct reports: 0-2
Years of experience: 6+ (Manager) 10+ (Senior Manager)
Degree:   Bachelor’s required; Regulatory, Quality or Engineering or technical preferred
Location:  Southeast US
Fri, 06 Apr 2018 00:00:00 EDT 1