position Title: Clinical Risk Evaluation Project Manager Assignment Duration: 08 Months Work Arrangement: Santa Clara, CA, Sylmar, CA, Plano, TX or St. Paul, MN; or Possibly Remote Someone that has previous experience working in medical device industry Understanding and working knowledge of Medical Clinical Research Understanding of Regulatory Guidelines and how it applies to the sites. Analytical and critical thinking skills along with related work experience,. Job Summary In this role, you will provide cross functional support to ensure the clinical safety and residual risk information of medical device products are aligned and consistent across product documentation and throughout the produce life cycle. This process supports compliance with quality management system and regulatory submission requirements. Years Experience: 5+ years of experience in relevant fields including health care, clinical research, medical writing, or combination of these in the medical device or pharmaceutical industry. Skills: strong communication, team player, technical writing skills, education: Bachelor’s Degree (Preferred: advanced degree in medicine, nursing or biomedical science) Duties:
The Clinical Risk Evaluation (CRE) Project Manager writes and manages product
master files of clinical risks, anticipated adverse events/side effects and safety information,
such as contraindications, warnings, precautions, critical warnings and restricted substances.
The CRE Project Manager must be able to effectively manage multiple projects and timelines in a fast-paced and diverse environment in order to:
Lead and participate in the clinical risk evaluation process; review available medical device and procedure related clinical and risk data throughout the product life cycle;
Independently create and maintain Risk Evaluation Files (REFs) for the
company’s medical device products;
Lead Risk Alignment Committee (RAC) meetings and actively engage cross-functional stakeholders (Regulatory Affairs, Clinical Affairs, Medical Affairs,
Clinical/R&D Engineering, Quality, Product Labeling, and others as relevant);
facilitate and document informed decision-making with corresponding rationale;
Identify appropriate sources of data; interpret, and evaluate clinical safety data
from all available sources, including company-sponsored and other clinical investigations, post-market experiences and complaints, and scientific literature for anticipated adverse event frequencies;
Review global Instructions for Use (IFUs), clinical investigation documentation and physician training material, Risk Management Reports (RMR),
Clinical Evaluation Reports (CER), Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performance (SSCP) to ensure clinical risk disclosure information alignment between documents;
Support global regulatory submissions; ensure ongoing, proactive communication
and engagement with Regulatory Affairs and other relevant stakeholders during the
submission process;
Support business unit responses to queries from regulatory authorities, ethics committees or institutional review boards related to clinical risk disclosure information;
Maintain working knowledge of assigned products and therapeutic areas;
Support continuous process improvement activities;
Be responsible for compliance with applicable corporate and divisional policies, procedures and training. Ensure compliance to applicable regulations and guidelines (including ISO13485, ISO14155, ISO14791, MEDDEV 2.7/1 Rev.4,
EU MDD/AIMDD/MDR and MDCG/FDA guidance documents).
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.