Job Title: Safety Specialist (Remote)

Contract Length : 12 months (extension possibilities)

Description

This position will be responsible for providing medical and clinical expertise to support patient safety throughout the product life cycle.

The Safety Specialist is a patient safety advocate and participates in various activities in collaboration with cross-functional team members, including Quality, Regulatory Affairs, Research and Development, Complaint Handling, and Design Quality to support product safety and efficacy.

Essential duties and responsibilities:

1. Evaluate post-market events to identify a potential safety issue and ensure correct
2. Escalate newly identified potential safety issues for further
3. Provide clinical expertise to support the responses to safety inquiries from internal stakeholders, Food and Drug Administration, or global competent authorities and regulators.
4. Author Medical Safety Assessments for post-market events with a recommended course of
5. Author Health Hazard Evaluation to assess the risk of patient harm and present summary of analysis to leadership.
6. Collaborate and provide clinical expertise and knowledge for new products, clinical studies, technical file remediation, and change development
7. Serve as expert reviewer for the Post-Market Surveillance Plan and Clinical Evaluation Report.
8. Provide safety input to risk management
9. Participate in the development and maintenance of Medical Safety processes and Standard Operating

Essential qualifications:

1. Minimum of ten (10) years of clinical nursing involving direct patient care, preferably in Medical/Surgical and/or Intensive Care Unit (ICU).
2. Knowledge of quality improvement and patient safety across the care
3. Ability to assess clinical outcomes, analyze data, summarize, and present
4. Ability to perform comprehensive literature
5. Proficient in Microsoft Office applications, including Excel, Word and
6. Excellent written and oral English communication
7. Project management

Core skills:

1. Strong work ethic, patient focus, and commitment to serve internal and external
2. Proactive with a sense of urgency in managing job
3. Energy, focus, motivation and debate
4. Analytical thinking and inquisitive mindset for investigations and problem
5. Team player, "can-do" attitude, and excellent interpersonal
6. Ability and desire to develop good working relationships internally and
7. Practice and share accountability with others for a positive team spirit characterized by mutual support of corporate culture, understanding, encouragement.

Education

Bachelor's Degree in Nursing required, Advanced Practice Nurse or Master's level degree preferred.

Active nursing license.