Regulatory Affairs Manager (Russia and CIS)

☑ Основной блок:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 22551646 добавлено в базу данных: Суббота, 15 февраля 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Репутация компании "Smith & Nephew (Смит энд Нефью)":

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☑ Подробности о вакантном месте:

Smith & Nephew is a global advanced medical technology business. We support healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We are looking for a Regulatory Affairs Manager based in Moscow, Russia. The main purpose of this role is to ensure product registrations and regulatory compliance in Russia and CIS.

Your main main responsibilities will be:

• Ensure accurate planning and timely registration of new products according to the business needs and effective maintenance and renewal of existing registration certificates. Establish and maintain an accurate filing system for all Regulatory Affairs activities within each franchise and for each product as required.
• Improve product registration process including interaction with the other functions and external parties to ensure smooth product registration without undue delay.
• Ensure product compliance with the legal requirements and S+N Policies and procedures
• Develop and maintain product databases and relative products licenses on the market.
• Tracking changes in current and new regulatory requirements and rules in Russia and CIS countries and ensuring the Company's compliance with the applicable laws and regulations.
• Ensure compliance to applicable quality standards (ISO 9001, ISO 13485) and Medical Device regulations review and update existing procedures/work instructions or create the new one if required to ensure compliance, efficiency and clarity.
• Identify and lead the elimination of regulatory risks, if any
• Interacting and liaising with Competent Authorities as part of the field action, vigilance and post-market surveillance activities
• Oversight of the post-market activities in Russia and CIS countries
• Review and approve advertising and promotional material, including product labelling, conference material, and product claims for regulatory compliance.
• Provide answers to technical and regulatory enquiries from customers and/or colleagues to support their business activities and meet requirements as well as provide information and documents for specific requests (clinical data, literature references, statements) and translation of the documents.
• Planning the budget of the registration and quality departments
• Development of the regulatory department team
• Represent the company during external audit/inspection

Requirements:

• Experience in medical device regulations in Russia for 3-5 years;
• Updated and comprehensive knowledge of local regulations, and ability to translate them into actionable strategies;
• Fluent English;
• Strategic thinking, organizing and planning;
• Effective negotiation and influencing;
• Resilient, clear thinking, and able to make decisions and recommendations;
• Strong regulatory strategy planning and execution capabilities;
• Clear and actionable communication;
• Accurate sense of urgency, prioritization and delegation;
• Knowledge of ISO 9001 and or ISO 13485 as a plus.

We offer

• An interesting and varied function in an international and interdisciplinary environment;
• The opportunity to play a relevant part in a medical network and to further develop a company with an excellent reputation;
• Competitive compensation package and social benefits

☑ О компании:

Логотип (эмблема, торговая марка, бренд) компании:

Сфера деятельности компании: Медицина, фармацевтика, аптеки; Промышленное оборудование, техника, станки и комплектующие; .

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