Keira Jessop is a Director of Regulatory Affairs at AlvaMed with 20 years of experience in the medical device industry with her principal experience in building the technical documentation to support regulatory submissions. Keira has supported various new product development projects, contributing her expertise to multiple Class II and Class III devices.
Keira’s achievements include the following:
- Serving as the primary regulatory team member throughout all design control phases, successfully launching a novel tampon in the US.
- Leading the regulatory activities for multiple 510(k) clearances and commercial launch of a rotator cuff repair system, including the associated fixation devices and instruments in the US.
- Overseeing the creation and responses of an orthopedic company’s first technical documentation file under the EU Medical Device Regulation (EU) 2017/745, which successfully achieved approval by the notified body.
- Achieved the simultaneous transition of European notified bodies for four US based business units.
Keira also has experience with:
- Regulatory strategies
- Regulatory assessments of device design and manufacturing changes
- PMA annual reports and supplements
- Regulatory change notifications and license amendments
- Post market surveillance activities
- Promotional material review
- Risk Management Activities under ISO 14971
Keira holds a B.S. in Biomedical Engineering from Texas A&M University and a M.S. in Engineering Management from New Jersey Institute of Technology. Keira holds a Regulatory Affairs Certificate and is a member of the Regulatory Affairs Professional Society. She also received a Six Sigma Black Belt Certification from Johnson & Johnson and previously held a Quality Engineer Certification.
