Digital Compliance Specialist Life Science
Posted on Oct 1, 2021 by Red - The Global SAP Solutions Provider
Digital Compliance Specialist Life Science/Remote/3 months/ASAP
Required Knowledge, Skills and Abilities:
- Experience working with regulatory and compliance functions within medical device/pharmaceutical industries strongly preferred.
- Understanding of medical device/pharmaceutical regulations for software from U.S. and OUS authorities required.
- Exposure to current practices for software as medical devices required, including risk analyses, verification and validation, design reviews
- Experience with software development practices required.
- General understanding of cyber security standards and security compliance required.
- Exceptional analytical and creative problem solving skills; self-starter and solution-oriented individual that can act independently and run a team
- Ability to make risk-based decisions.
- Ability to solve complex business problems and present recommendations to senior management effectively
- Strong verbal and written communication skills
- Ability to function as part of a broader organisational team is also required.
- Big picture orientation with strong attention to detail is required.
- Collaboration skills and the ability to build strong win/win relationships with partners are required.
- A results and performance driven attitude with strong sense of accountability and drive to get results is required.