Principal Regulatory Affairs Specialist - Diabetes Care (on-site)
Alameda, CA On-site
$100,000–$200,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs. Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. The individual has department level influence with experience in US submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
What you'll bring
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Combination Devices, In Vitro Diagnostic Devices and/or Medical Devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs.
- Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, US Device regulations, or with EU and other international medical device regulations and submissions.
- Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.