Discover a new way to develop regulated software
Compliance Lead
Join our R&D team and build the Ketryx platform
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
Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Due to Austrian law we are obliged to quote the minimum yearly gross salary of € 35,042, in accordance with the respective collective agreement (IT-KV). The salary that Ketryx offers you is adjusted to the current market situation and does significantly exceed it.