Mountain View, United States
over 1 year ago
The Ultrasound Division of Siemens Healthineers is looking for a Regulatory Clinical Affairs Specialist. EU MDR for our Mountain View, CA or Issaquah, WA location.
The Regulatory Clinical Affairs Specialist, EU MDR is a member of the Clinical Affairs team and he/she shall plan, coordinate and implement Standard Operating Procedure (SOPs)/Work Instructions (WIs), templates and trainings for various stakeholders related to Clinical Lifecycle Management for Siemens Ultrasound systems and intracardiac echocardiography (ICE) catheters.
This position is responsible for supporting implementation of European Medical Device Regulations (EU MDR) within the Quality Management System.
- Participate in communications regarding overall direction and guidance to the cross-functional project team on clinical evaluation, PMCF and clinical development activities.
- Plan, execute, and finalize all QMS deliverables for clinical workstream for CE marking products per MDR including but not limited to clinical evaluation plan (CEP), CER, PMCF plan, PMCF Report, Summary of safety and clinical performance etc.
- Coordinate efforts of project teams with third party/outsourcing vendors to achieve clinical deliverables.
- Identify, effectively communicate and resolve EU MDR project issues, risks and develop mitigation plans.
- Effectively communicate project status to project stakeholders and EU MDR core team.
- Develop training materials and support overall training strategy for all stakeholders including but not limited to Foster Product Managers, Risk managers and Post-market managers into the CE marking deliverables for each project.
- Provide support as need during internal as well as external Audits by TUV and FDA
- Prioritize robust SOPs/WIs and templates at all times and identify continuous areas of improvement.
- Proactively work to improve systems and procedures and act as a cross-functional liaison with legal, quality, product management and clinical teams.
- Develop/maintain SOPs, processes, and templates to strategically standardize clinical tasks and improve efficiency.
- Perform periodic reviews of risk management files, usability engineering files, product labeling, and marketing claims as part of the clinical evaluation process.
Education and Knowledge
- BS/BA with 7 + years or MS with 5+ years experience in clinical and/or regulatory affairs
- Demonstrated project management and planning experience.
- Demonstrated problem solving capability and results orientation.
- Experience in research methodology (clinical investigation design, biostatistics), scientific literature review (PUBMED, EMBASE, MEDLINE etc.) and medical writing.
- Experience of FDA (21 CFR 212, 21 CFR 820 etc.) , EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards.
- Strong critical/analytical thinking and problem solving skills.
- Strategic planner, self-starter, collaborative team player and clear thinker.
- Excellent interpersonal, written / verbal communication and presentation skills.
- Ultrasound and/or imaging catheter experience preferred.
- Experience with regulatory submissions for EU Class III devices .
- Advanced degree (MD, PharmD, PhD etc.) and experience in radiology, cardiology and medical imaging.
- In-depth understanding of EU MDR and Risk Managemen.
- Experience in claims management and mapping clinical evidence to clinical claims.
- Experience In EU clinical trials and experience with Institutional Review Boards (IRB) and Ethics Committee (EC).
- Regulatory Affairs experience for EU CE Marking and supporting technical documentation.
Key Working Relationships
Works with a cross functional team.