When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.
How Will You Make an Impact?
The Senior Regulatory Affairs Specialist will ensure that all of our products have the functionality necessary to comply with stated regulatory intentions by working effectively with individual product managers. Will represent the Digital Science Business Unit at external and customer meetings, and will work with the Customer Success team to ensure that any new Software Defects that could affect regulatory compliance are categorized and triaged appropriately.
What will you do?
- Possess a deep understanding of relevant regulations and keep up with these regulations as they evolve
- Identify and become competent in any new regulations that are relevant to our Business
- Identify necessary product changes as a result of evolving regulations and communicate these changes to product management
- Represent the Digital Science Business Units compliance capabilities at internal and external events such as industry conferences, customer events, regulatory forums and pre-sales meetings
- Deliver presentations at internal and external events
- Act as subject matter expert when reviewing Software Issues for their impact on regulatory compliance
- Chair meeting (approx. quarterly) of senior managers to discuss communication and dispositioning of Software Issues that are directly causing regulatory compliance
- Assist Quality group with QMS improvement and maintenance as necessary
- Assist BU in ongoing compliance with SOC/HIPAA/Validated cloud as necessary
- Support customer success team with regulated customer deployments as necessary (e.g. infrastructure change control)
How will you get there?
- Bachelors degree required. Advanced degree a plus.
- 10 + years in the Life Science industry
- Deep understanding of current regulations in life sciences (GMP, GLP, 21 CFR Part 11, GAMP, SOC, HIPAA)
- Understanding of Computer System Validation
- Experience of working with IT systems such as LIMS
- Understanding of Data Integrity Challenges facing pharmaceutical industry
- Excellent presentation skills
- Excellent verbal and written skills
- Ability to travel 25% on an annual basis
This position has not been approved to provide relocation assistance.
Apply on company website