Location:

San Jose, CA

Duration:

Full-time, On-site

Description:

Under the direction of the Clinical Evaluation Report Project Manager (CER PM) and Director:

• Author and develop clinical evaluation documents per Abbott processes, procedures, and templates, which may include Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Post-Market Surveillance (PMS) Plan, Post-Market Clinical Follow-up (PMCF) Plan, PMCF Report, Summary of Safety and Clinical Performance (SSCP).
• Analyze and synthesize vast amount of pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance.
• Interface with CER PM and key functional areas (e.g., Product core teams, clinical team, EU and US regulatory, marketing risk management group) to obtain necessary information and documents required for the development of CERs.
• Develop therapeutic and device operation knowledge and apply this knowledge to clinical assessment and development of evaluation reports for corresponding product/s.
• May provide input and feedback to product core teams/members/teams in the determination of appropriate clinical evaluation strategy, and may provide input and direction to project teams in order to arrive at a sound clinical evaluation.
• Collaborate with cross-functional team to assure high quality and successful completion of deliverable.
• May be requested also to:
  • Interface with regulatory agencies to discuss details of the clinical evaluation report, including clinical assessment results.
  • Participate and/or facilitate meetings with health care professionals, consultants and internal scientific or tactical committees.
  • Critically evaluate project progress and metrics.
  • Collaborate with cross functional team to identify risks and mitigation plans.
  • Manage project schedule, timelines and deliverables.
  • Participate in process improvement initiatives.
  • Provide work guidance to colleagues
• Other relevant duties as required

Education:

Bachelor’s degree required; Master’s or PhD preferred with a focus in science, engineering, or medical fields.

Requirements:

• 5+ years of experience in a medical, clinical research, quality systems setting; regulatory experience in medical device or pharmaceuticals industry is preferred.
• MUST have CER writing experience and be proficient in all aspects of authoring clinical evaluation documents.
• Understanding of regulations, standards and guidelines related to medical devices, clinical studies, and quality systems, including: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; EU MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
• Effective written, verbal and presentation skills in English in the area of technical/clinical applications.
• Strong command of medical terminology.
• Highly-developed interpersonal skills, and strong attention to detail.
• Advanced experience with MS Office suite.

To Apply:

Send your resume (in Microsoft Word format), as well as your desired hourly rate, to: [email protected].