This role will be 100% remote, must work 9-3 core hours are respective time zone, working 8 hours per day **Job Description:** + The **Medical Device Safety** team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. + The team is a high-profile high-impact team that works with PSEQ functions on a range of product initiatives. + As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. **Experience & Skills:** + Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases + Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting) + Clinical Trial Experience + Clinical Trial Device Experience + Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Veeva, Argus, EDC Rave, Veeva EDC other database tools) + Ability to effectively interact with and influence others without direct reporting relationships + Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs. + Positive attitude, agile and flexible with change and ability to navigate the unknown or “gray area” **Core Essential Skills:** + Ability to Meet Challenging Milestones with results orientation – Skilled + Strategic Decision Making and Negotiation – Skilled + Facilitating Change and managing conflicts – Skilled + Ability to Problem Solve Independently & with Others - Highly Skilled + Business Organization & Industry Awareness - Highly Skilled + Cross Functional Relationships and communication skills - Highly Skilled + Execution / Results / Process Improvement - Highly Skilled **Background / Required and Preferred Education Level:** + Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing + RN Required **Top 5 skills/requirements this person is required** a. Required Skill 1: RN with clinical experience (minimum 2-3 years) b. Required Skill 2: Medical Device experience- either in complaint handling or in medical assessments of adverse events minimum 2+ years c. Required Skill 3: Exposure and/or knowledge of global medical device regulations. d. Required Skill 4: Critical thinking and application e. Required Skill 5: Ability to handle change well and worked under minimal direction About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.