Compliance Analyst - regulatory reporting (Cincinnati, OH)

Summit Field Medical designs and makes medical devices in Cincinnati, and we need a Compliance Analyst to lead our regulatory reporting. You would join a small organisation of about 16 people based in Cincinnati. What you will do • Keep the policy library current and easy to search. • Review processes against regulations and internal policies. • Train staff on requirements for clinical evaluations. • Prepare regulatory filings and audit evidence. • Track findings until they are fixed. What we are looking for • Comfort saying no politely. • Careful reading and clear writing. • Two or more years in compliance, audit or risk. Nice to have • Certification in compliance or audit. • Experience with device records. Working arrangement • Part-time, about 24 hours a week, spread across three days. • On site in Cincinnati. • Applications are reviewed on a rolling basis.