Roles and Responsibilities

• Maintain compliance of Intelerad’s product suite in alignment with US and International regulatory standards including, but not limited to 21CFR820, ISO13485, ISO27001 and SOC2

• Maintain a strong knowledge on international regulations including but not limited to MDSAP (FDA, HealthCanada, TGA and Anvisa), UKCA and EU MDR, and can convert regulations into an operational structure

• Coordinate regulatory documents, ensuring submissions are timely and regulatory objectives are met

• Compile all materials required for submissions, license renewals, and annual registrations

• Create and maintain processes that are in compliance with Regulatory authorities

• Act as a primary point of contact with regulatory agencies, and any Notified Body or Authorized Representatives, including such responsibilities as regulatory submissions and auditing

• Oversee regular audits of the departments to ensure compliance with procedures

• Ensure that the conformity of medical devices is checked before release, that any required technical documentation and Declarations of Conformity are developed and maintained, that post-market surveillance and reporting obligations are fulfilled

• Comply with all company policies and procedures

• Maintain a favorable working relationship with all company employees to foster and promote a cooperative and harmonious working climate

• Identify metrics across the organization, implement and track to develop efficiencies

Professional Qualifications

• Previous experience working in private equity preferred

• Experience in conducting research on a regulatory market to understand trends, identify key players and surface key points of differentiation

• Ability to work under pressure in a dynamic environment

• Excellent written and verbal communication skills

• Ability to operate both in the weeds as well as at a strategic / macro level

• Strong project management skills, having managed and successfully completed diverse projects on time and on-budget

• Strong cross-group collaborator with exceptional general management skills and the ability to build relationships within an organization

• Strong follow through and ability to see projects to completion without significant oversight required

• Ability to take a concept, internalize it, rally others around, drive its implementation, and identify ways to continuously improve it 

Required Experience

• Bachelor’s degree in Business, Computer Science, Information Systems Management, or a related field

• 10+ years of regulatory experience or in quality management system experience in healthcare

• Strong knowledge and/or experience with  HIPAA, GDPR and other privacy laws

• Strong technical aptitude and a quick learner with the ability to understand medical imaging

• Excellent analytical, research, organizational, decision-making and planning skills

• Proven track record of success in improving organizational processes

• Outstanding teamwork skills, and the ability to develop and maintain internal and external relationships

• Proven ability to influence cross-functional teams

• Exceptional communication, negotiation, and leadership skills

• Proven experience with ISO-27001 or equivalent

Personal Characteristics

At Intelerad, we live by our six core values to ensure everyone is focused on what matters. Learn more about what we look for in our team members here.