Medical Device Safety Analyst

Location: Remote

Contract Length: 1 year

Pay Rate: $40 - $50

Medical Device Safety Analyst

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 PPS 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.

Responsibilities:

• Assisting with ongoing continuous improvement projects spanning across departmental needs
• Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.
• Identify regional label variances and build tool to capture info for priority products and main competitors
• Participate in root-cause investigations into device failures and human factors-related use errors.
• Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed.
• Providing support for training and automation efforts

Skills, Knowledge, Experience:

• Ability to effectively interact with and influence others without direct reporting relationships
• Bachelor of Science
• Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
• Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, other database tools)
• Biomedical engineer or RN preferred
• Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
• 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)

Core Essential Skills:

• Business Organization & Industry Awareness
• Cross Functional Relationships and communication skills
• Facilitating Change and managing conflicts
• Execution / Results / Process Improvement
• Strategic Decision Making and Negotiation
• Ability to Problem Solve Independently & with Others
• Ability to Meet Challenging Milestones with results orientation

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.