This position is responsible for planning and coordinating the development of Clinical Evaluation Reports (CERs) for CE marking of Siemens Healthineers Ultrasound systems and intracardiac echocardiography (ICE) catheters.
- Provide overall direction and guidance to the cross-functional project team on clinical evaluation, PMCF and clinical development activities.
- Plan, execute, and finalize deliverables for CE marking products including but not limited to clinical evaluation plan (CEP), CER, PMCF plan, PMCF Report, Summary of safety and clinical performance etc. within the triple constraints of delivering on time, within budget and scope objectives.
- Acquiring resources and coordinating the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan.
- Identify, effectively communicate and resolve project issue, risks and develop mitigation plans.
- Effectively communicate project status to project stakeholders and top management.
- Support of FDA/TUV communication as well as management of Clinical Research Organizations/Outsourcing vendors and Key Opinion Leaders.
- Foster early involvement of Product Manager, Risk managers and Post-market managers into the CE marking deliverables for each project.
- Represent Development team during internal as well as external Audits by TUV and FDA
- Continuous assessment of operations against business and regulatory needs as well as initiation of process adjustments wrt Quality Management.
- 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
- PhD/MS in Health sciences related degree with 5+ years of experience in clinical and/or regulatory affairs or BS/BA with 7 + years related experience; preferably in a highly regulated medical solutions industry.
- Demonstrated program management and planning experience.
- Demonstrated strong leadership and execution of reaching critical program goals/milestones while meeting quality, performance, schedule, and budget constraints.
- 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.
- Expertise in systematic literature searches for safety, performance and state of the art, literature review and appraisal of clinical data.
- Experience of FDA (21 CFR 212, 21 CFR 820 etc.), EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards.
- Experience in marketing / clinical claims management and mapping clinical evidence to marketing/clinical claims.
- 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/or experience in radiology, cardiology or medical imaging.
- In-depth understanding of EU MDR, Risk Management and imaging?
- Collaborative team product development processes / requirements.
- 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 RelationshipsWorks with a cross functional team.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.