Regulatory Affairs Specialist

Job SummaryResponsible for ensuring compliance of the company's orthopedic medical devices and manufacturing facility with applicable regulatory requirements.

Manages product registrations, technical documentation, facility licenses, regulatory submissions, inspections, and communication with regulatory authorities to support business continuity and market access.

Key ResponsibilitiesPrepare and maintain product registrations and regulatory submissions.

Manage technical files, labeling, and regulatory documentation.

Ensure compliance with applicable medical device regulations and standards.

Obtain, maintain, and renew all facility licenses, permits, and certifications.

Assess regulatory impact of product, process, and facility changes.

Coordinate regulatory inspections, audits, and responses to findings.

Monitor regulatory updates and implement required changes.

Support new product development and market expansion activities.

Serve as the primary contact with regulatory authorities and certification bodies.

RequirementsBachelor's degree in Pharmacy, Biomedical Engineering, Engineering, VET, Science, or a related Medical BG field. 1–3 years of experience in Regulatory Affairs within the medical device industry (orthopedic experience preferred).

Strong knowledge of medical device regulations, product registration processes, and quality systems.

Familiarity with ISO 13485, GMP, risk management, and technical documentation requirements.

Experience dealing with regulatory authorities and certification bodies.

Strong analytical, organizational, communication, and documentation skills.

Proficient in Microsoft Office and document management systems.

Preferred QualificationsExperience with orthopedic implants and surgical instruments.

Knowledge of Egyptian medical device regulations.

Experience managing both product registrations and manufacturing facility licensing.