Description:

The Chief Compliance Officer and Regulatory attorney will maintain a key role in ensuring Vero's compliance with local, state and federal regulations, while ensuring compliance with all regulatory agencies. The CCO/RA will advise on a number of legal topics to include medical device reporting, quality system regulations, manufacturing activities among many others. This role will also be responsible for ensuring ethical and responsible compliance.
  • Provides effective leadership to ensure the compliance with local, state and federal regulations and continued development of systems and procedures
  • Review company compliance policies and practice on a regular basis to ensure that all are in compliance
  • Partner with Regulatory Affairs and Quality Assurance to assist and counsel on all medical device regulations such as early R&D activities, product approvals, commercialization and life cycle management
  • Provide legal support in connection with inspections and investigations by the FDA
  • Assist with drafting and preparing policies, procedures, product manuals, legal guidance documents and training materials.
  • Monitor the external regulatory and enforcement agencies to identify and mitigate risks
  • Review proposed action plans to ensure compliance
  • Develops materials and training at an institutional level for distribution to all employees to enhance awareness of compliance activities. Coordinates internal compliance review and monitoring activities, including periodic reviews of departments.
  • Independently investigates and acts on matters related to compliance, including the flexibility to design and coordinate internal investigations (e.g., responding to reports of problems, 'hot-line' calls, or suspected violations).
  • Other duties as assigned

Qualifications:
  • Juris Doctor degree from accredited law school.
  • 7 + years experience in regulatory & compliance law
  • Must have license in good standing to practice law
  • Excellent verbal and written communication skills.