CooperSurgical
Regulatory Affairs Specialist (Biotech)
Regulatory Affairs Specialist (IVDs)
Oversees/Manages the regulation process for products requiring regulatory agency licensing, registration or clearance, including filing necessary applications/submissions. Coordinates the accumulation of technical information and creates submissions for medical devices including in vitro diagnostics (IVDs) for approval, license, registration or clearance in any region.
Essential Duties and Responsibilities include the following:
Education:
Certificates, Licenses, Registrations: RAC certification is preferred.
Other Skills and Abilities: Knowledge and understanding of US, EU MDR/IVDR and international medical device regulations.
Experience:
• Regulatory: 5 years (Required)
• IVDs 510(k): 2 years (Required)
• FDA, EU, Canada: 4 years (Required)
CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
See Job Description