Regulatory Affairs Officer

About Hanna Industries

We spun out of a university lab in 1962 and are funding our first IND-enabling studies. We started in 1962 and have grown to about 20 people. Lab coats, safety glasses and closed-toe shoes in all lab areas.

About the role

Hanna Industries is hiring a Regulatory Affairs Officer to support 510(k) and De Novo submissions for our cardiovascular device portfolio. This is an in-person role at our Giza location.

Essential duties and responsibilities

• Support EU MDR technical documentation and notified body reviews
• Monitor new guidance documents and summarise changes for the business
• Write and compile Module 3 CMC sections in eCTD format
• Track submission timelines and commitments in Veeva Vault RIM or a similar system
• Build regulatory strategy memos for new products and line extensions
• Coordinate with international distributors on country registrations

What we're looking for

• Bachelor's degree in a life science, engineering or pharmacy
• Clear technical writing and careful editing
• Knowledge of ISO 13485 and ISO 14971 for device roles

Schedule: Monday to Friday, standard business hours

Benefits

Rate: EGP 24,000 - EGP 29,000 monthly

• Annual leave
• Data and airtime allowance
• 13th month salary

Please submit your CV in English.

Start: Flexible.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Hanna Industries LLC.