Regulatory Affairs Specialist

BYC provides solutions for a variety of startups and growing companies.

One of our Clients is a Medical Company

Job Description:

• Responsible for managing regulatory registration processes of pharmaceuticals, dietary supplements, and medical devices with health authorities.
• Preparation of registration dossiers for health authorities and tracking their status.
• Writing and updating consumer leaflets, packaging, labels, and product dossiers.
• Ensuring compliance with regulatory requirements, updating professional information, and supporting new products or modifications of existing products.
• Monitoring regulatory changes and updating policies accordingly.

Requirements:

• Valid Israeli pharmacist license.
• Minimum 4-5 years of professional experience in registration of medical products, including submitting changes, renewals, and applications to the Ministry of Health according to Israeli law.
• Experience in pharmacovigilance: managing adverse events, updating leaflets for consumers and physicians, reviewing and submitting PSUR reports according to guidelines.
• Advantage: experience in medical device registration (Medical Devices).
• Good command of English – mandatory.
• Ability to work independently, with thoroughness, organization, and attention to detail.
• Excellent interpersonal skills and ability to work in a team.