The company is looking to solve the problem of ensuring the quality and compliance of its on-market medical devices, including Software as a Medical Device (SaMD), across the globe.
Requirements
- Working knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)
- Experience compiling and submitting regulatory applications and submissions
- Familiarity with SaMD is preferred
- Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) preferred
- Lead Auditor Certified, preferred
- Regulatory Affairs Certification (RAC), preferred
- Thorough knowledge of ISO 13485 quality system requirements
Responsibilities
- Maintain and monitor Quality Management System (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR
- Perform design control activities focused on 21 CFR 820, ISO 13485, and IEC 62304
- Manage Risk Management Process in compliance with ISO 14971
- Manage and guide system testing activities, including verification and validation
- Lead resolution of quality issues with on-market device software; drive investigations related to product nonconformities and implement CAPA plans
- Coordinate post-market activities including surveillance, trend reporting, adverse event reporting, and field safety corrective actions
- Prepare documentation and third-party testing for US and global registrations, license renewals, new product registrations, and product change registrations
Other
- Bachelor’s Degree required. Clinical Degree preferred (e.g. PharmD / pharmacist, M.D. / medical doctor, etc.)
- 5+ years of quality and risk experience related to software as a medical device sold in the U.S., E.U., and globally
- Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry
- Must have E.U. MDR and FDA Class II medical device experience, focused on software as a medical device
- Be a detail-oriented with technical writing skills
- Ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders
- Possess interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and initiative continuous improvement
- Travel is minimal and tends to be irregular in frequency
