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Compliance Lead

Join our R&D team and build the Ketryx platform

Engineering & Data
About Us

Ketryx is making software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. Our developer-first approach ensures safety and reliability is ingrained into healthcare products from the ground up, leading to increased developer productivity, patient satisfaction, revenue growth, and cost savings

Job Description

This is a full-time position with remote options for a compliance expert with an auditing background. You will be in a leadership position, working closely with the customer success team to ensure the client's products, as well as Ketryx’s own system, follow proper risk management and adhere to established guidelines determined by the FDA. You will work closely with the CEO, CTO, and Director of Customer Success and Product Development on a daily basis. Location: Vienna, Austria preferred.

About You
  • You have at least 5 years of experience in auditing and compliance

  • You enjoy working in a fast paced, ever-changing environment

  • You have former experience as an Auditor at a Certifying Body. E.g. UL, TÜV SÜD, Intertek (a plus)

  • You are familiar with ISO 13485 and IEC 62304, CFR 21 Part 11, CFR 21 Part 820, and ISO 14971

  • GMP Experience (a plus)

  • You have a background in biotechnology (a plus)

  • You have management and leadership experience

  • You are a fast learner able to absorb information and relay details to clients in a clear and concise manner

  • You have experience with HIPPA, GDPR, HITRUST (a plus) 

  • You have effective verbal, written communication, presentation skills with diverse audiences

  • You have former software development, QA, and automation experience (a plus)

  • You have a familiarity with the regulated product development process and FDA regulations (a plus)

  • Vienna, Austria local preferred; remote possible

About the Role
  • Manage and enforce an effective healthcare and life science compliance program that’s in line with both national and global regulatory standards

  • Support customers in their medical compliance journey

  • Build and lead a team of compliance experts 

  • Expand and review company policies and other QMS documentation 

  • Provide management reports by collecting, analyzing, and summarizing management information

  • Conduct internal audit work and document audit tests and findings

  • Recommend to the management team on the current company’s compliance with laws and regulations

  • Update job knowledge by participating in educational opportunities like reading professional publications, maintaining personal networks, and participating in professional organizations

  • Meet work standards by following production, productivity, quality, and customer-service standards; resolving operational problems; and identifying work process improvements

  • Ensure compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation; and recommending opportunities to strengthen the internal control structure

  • Verify assets and liabilities by comparing items to documentation

What We Offer
  • Competitive salary and generous stock options

  • Work in an exciting field with a positive impact on the world

  • Flexible working hours

  • Remote work options

  • Offices in Vienna and Boston

  • Generous PTO

  • Opportunity to learn and grow as part of a global team

Apply for this Role