Key Responsibilities
- Support FDA 510(k) submissions and maintain DHF, DMR, and technical documentation.
- Contribute to regulatory strategies for U.S., EU MDR, and UK markets.
- Support QMS processes including CAPA, complaints, audits, post-market surveillance, and continuous improvement.
- Ensure compliance with FDA QMSR, ISO 13485, IEC 62304, ISO 14971, and IEC 62366.
- Evaluate software changes, releases, and regulatory impact assessments.
- Assist with cybersecurity, risk management, field actions, and corrective action activities.
- Collaborate cross-functionally to ensure regulatory and quality compliance across product development.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
- 5+ years of Regulatory Affairs within medical devices or SaMD.
- Hands-on FDA 510(k) submission experience.
- Strong knowledge of FDA QMSR, ISO 13485, IEC 62304, ISO 14971, and applicable regulations.
- Experience preparing EU MDR technical documentation is a bonus.
- Candidates must be willing and able to relocate to Wisconsin for this role.