Regulatory Affairs Specialist

Regulatory Affairs Specialist – Egypt

Kelly Science, Engineering, Technology & Telecom | Egypt (Remote)

Employment Type: Full-Time, 12-Month Fixed-Term Contract

Location: Remote, Egypt

Start Date: Immediate

Contract: Initial 12-month FTC, with potential for extension

About the Opportunity:

Kelly Science, Engineering, Technology & Telecom is recruiting for an exciting opportunity with a leading global medical technology organisation. The client develops innovative healthcare products and solutions that support patients, healthcare professionals and healthcare systems worldwide.

With an established international presence and a broad portfolio of medical devices, the organisation is committed to advancing healthcare, improving patient outcomes and maintaining the highest standards of product quality, safety and regulatory compliance.

This opportunity is being offered through Kelly's FSP (Functional Service Provider) model, where you will be employed by Kelly and assigned to the client's regulatory team.

We are looking for an experienced Regulatory Affairs professional based in Egypt who can act as the primary local regulatory representative, supporting the client's medical device portfolio and working closely with the local distributor.

This is a hands-on regulatory role, offering the opportunity to take ownership of local regulatory activities, provide expert guidance and work directly with an international medical technology organisation.

Key Responsibilities

• Act as the primary local Regulatory Affairs contact and representative for the client in Egypt.
• Work closely with the local distributor to support regulatory activities for the client's medical device portfolio.
• Support and coordinate regulatory submissions to the Egyptian Drug Authority (EDA).
• Prepare, review and organise regulatory documentation, submission packages and supporting materials.
• Provide hands-on regulatory expertise and guidance to the distributor, helping them understand and meet local medical device requirements.
• Maintain awareness of the Egyptian medical device regulatory landscape, including relevant rules, requirements and procedural changes.
• Support regulatory queries, documentation requests and follow-up activities with the distributor and internal client stakeholders.
• Coordinate with internal Regulatory Affairs and cross-functional teams to ensure local requirements are understood and addressed.
• Maintain regulatory records, trackers and internal systems, including MDRiM and other relevant regulatory administration activities.
• Ensure regulatory activities are appropriately documented, tracked and escalated where required.
• Contribute to the ongoing maintenance of regulatory compliance and effective communication between the client, distributor and relevant stakeholders.

Candidate Requirements:

Essential Experience

• Previous experience in Regulatory Affairs within the medical device industry.
• Hands-on experience supporting medical device regulatory activities in Egypt.
• Practical knowledge of the Egyptian Drug Authority (EDA) and local regulatory requirements for medical devices.
• Experience preparing, reviewing or coordinating medical device regulatory submissions and documentation.
• Ability to provide regulatory guidance and work directly with distributors or local regulatory stakeholders.
• Strong understanding of regulatory processes, requirements and compliance expectations within the Egyptian medical device market.
• Strong organisational skills, attention to detail and the ability to manage multiple regulatory activities.
• Fluent or professional-level English, with strong written and verbal communication skills.

Desirable Experience

• Experience acting as a local regulatory representative or primary regulatory contact.
• Experience working with a multinational medical device company or through an FSP environment.
• Familiarity with internal regulatory information systems, including MDRiM.
• Experience managing distributor relationships and supporting regulatory submissions from document preparation through to follow-up.
• Experience across multiple medical device product categories or regulatory pathways in Egypt.

What Kelly Offers:

Through Kelly's FSP model, you will be employed by Kelly and assigned to a global medical technology client for an initial 12-month fixed-term contract, with potential for extension depending on project requirements and performance.

This remote-based opportunity offers the chance to become a dedicated regulatory specialist supporting the client's local market while collaborating with international colleagues and distributor partners.

The role provides valuable exposure to local regulatory strategy, distributor engagement and regulatory operations within a global medical device environment.

Apply Now:

Candidates with relevant medical device Regulatory Affairs experience in Egypt, particularly those with EDA experience, are encouraged to apply.

This is an immediate requirement, and the client is looking to progress suitable candidates quickly.

Employment: Kelly Science, Engineering, Technology & Telecom, under an FSP model.

Contract: 12-month FTC, with potential for extension.

Location: Remote, Egypt.

Start: As soon as possible.

Client: Global medical technology organisation, name confidential at this stage.